CN102307650B - System and method for filling the dialysis system - Google Patents

System and method for filling the dialysis system Download PDF

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CN102307650B
CN102307650B CN200980148019.8A CN200980148019A CN102307650B CN 102307650 B CN102307650 B CN 102307650B CN 200980148019 A CN200980148019 A CN 200980148019A CN 102307650 B CN102307650 B CN 102307650B
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valve
state
dialysate
manifold
fluid
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CN200980148019.8A
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CN102307650A (en
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巴里.N.福尔克森
马丁.赫林
弗兰克.伊萨克森
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弗雷塞尼斯医疗保健控股公司
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Priority to US61/103,274 priority
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Priority to PCT/US2009/059906 priority patent/WO2010042666A2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3643Priming, rinsing before or after use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators; Reciprocating systems for treatment of body fluids, e.g. single needle systems for haemofiltration, pheris
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators; Reciprocating systems for treatment of body fluids, e.g. single needle systems for haemofiltration, pheris with membranes
    • A61M1/1694Dialysis systems; Artificial kidneys; Blood oxygenators; Reciprocating systems for treatment of body fluids, e.g. single needle systems for haemofiltration, pheris with membranes with recirculating dialysing liquid
    • A61M1/1696Dialysis systems; Artificial kidneys; Blood oxygenators; Reciprocating systems for treatment of body fluids, e.g. single needle systems for haemofiltration, pheris with membranes with recirculating dialysing liquid with dialysate regeneration
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. haemofiltration, diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. haemofiltration, diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3424Substitution fluid path
    • A61M1/3437Substitution fluid path downstream the filter, e.g. post-dilution with filtrate
    • AHUMAN NECESSITIES
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. haemofiltration, diafiltration
    • A61M1/342Adding solutions to the blood, e.g. substitution solutions
    • A61M1/3455Substitution fluids
    • A61M1/3465Substitution fluids using dialysate as substitution fluid
    • AHUMAN NECESSITIES
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3643Priming, rinsing before or after use
    • A61M1/3644Mode of operation
    • AHUMAN NECESSITIES
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3643Priming, rinsing before or after use
    • A61M1/3644Mode of operation
    • A61M1/3646Expelling the residual body fluid after use, e.g. back to the body
    • AHUMAN NECESSITIES
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3643Priming, rinsing before or after use
    • A61M1/3644Mode of operation
    • A61M1/3647Mode of operation with recirculation of the priming solution
    • AHUMAN NECESSITIES
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3643Priming, rinsing before or after use
    • A61M1/3644Mode of operation
    • A61M1/3649Mode of operation using dialysate as priming or rinsing liquid
    • AHUMAN NECESSITIES
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3643Priming, rinsing before or after use
    • A61M1/3644Mode of operation
    • A61M1/365Mode of operation through membranes, e.g. by inverted trans-membrane pressure [TMP]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3643Priming, rinsing before or after use
    • A61M1/3644Mode of operation
    • A61M1/3652Mode of operation using gas, e.g. air
    • AHUMAN NECESSITIES
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    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3672Means preventing coagulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators; Reciprocating systems for treatment of body fluids, e.g. single needle systems for haemofiltration, pheris
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators; Reciprocating systems for treatment of body fluids, e.g. single needle systems for haemofiltration, pheris with membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/128General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated valves
    • AHUMAN NECESSITIES
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3324PH measuring means
    • AHUMAN NECESSITIES
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
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    • A61M2205/3368Temperature
    • AHUMAN NECESSITIES
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    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • A61M2205/3372Temperature compensation
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00Fluid handling
    • Y10T137/0318Processes
    • Y10T137/0402Cleaning, repairing, or assembling
    • Y10T137/0491Valve or valve element assembling, disassembling, or replacing

Abstract

本申请涉及能够利用透析液充灌系统的体外血液处理系统。 The present application relates to extracorporeal blood processing system to use dialysis fluid filling system. 塑料模制的紧凑歧管支撑模制的血液和透析液流体通路以及相关的传感器、阀和泵。 Compact manifold tube support made of plastic molded blood and dialysate flow path and associated sensors, valves and pumps. 紧凑歧管在一个实施例中还是一次性的,并且能够可拆卸地安装在透析设备中。 In one compact manifold embodiment or embodiments of the disposable and detachably mounted in the dialysis apparatus. 在歧管中的双路阀用于导向透析液流动通过血液回路以充灌用于治疗的回路。 Two-way valve in the manifold for the fluid to flow in the circuit filling guide for the dialysis treatment by the blood circuit.

Description

用于透析系统的充灌系统和方法 System and method for filling the dialysis system

技术领域 FIELD

[0001] 本发明涉及用于通过透析液充灌血液回路的系统和方法,特别地,涉及一次性歧管,其能够在充灌操作模式和治疗操作模式之间自动地切换。 [0001] The present invention relates to systems and methods for filling the dialysate through the blood circuit, in particular, it relates to a disposable manifold that is capable of automatically switching between the operating mode and the filling mode of operation of the treatment.

背景技术 Background technique

[0002] 血液透析用于在肾衰竭的情形下从人体移除有毒废物。 [0002] hemodialysis for removing toxic waste from the body in the case of kidney failure. 病人血液经由管子被临时带到身体外面并通过透析器中的至少一个半渗透膜,所述膜可以是一组中空纤维。 The patient's blood via a tube and is temporarily taken out of the body through the dialyzer at least one semi-permeable membrane, the membrane may be a group of hollow fibers. 半渗透膜从透析液溶液分离血液。 Semi-permeable membrane separating the blood from the dialysate solution. 来自血液的杂质通过膜并主要通过渗透压力进入到透析液溶液中。 Impurities from the blood into the dialysate solution through the membrane and primarily by osmotic pressure. 清洁后的血液然后返回到身体。 The cleaned blood is then returned to the body.

[0003] 利用在医院中安装的设备的标准透析治疗包括两个阶段,也就是,(a)透析,其中有毒物质和渣子(通常为小分子)从血液通过半透膜到透析液体,和(b)超滤,其中血液回路和透析液回路之间的压差,更准确地说,透析液回路中降低的压力,使得水中的血液含量减少预定量。 [0003] With the device installed in a standard hospital dialysis treatment comprises two stages, i.e., (A) dialysis, where toxic substances and waste products (usually a small molecule) through the semipermeable membrane from the blood to the dialysis liquid, and ( the pressure difference between b) ultrafiltration, wherein the blood circuit and the dialysate circuit, and more specifically, the dialysate circuit in a reduced pressure, so that the water content of the blood is reduced by a predetermined amount.

[0004] 利用标准设备的透析程序除了需要患者身处透析中心很长时间之外趋于笨重且昂贵。 [0004] using standard procedures in addition to the dialysis apparatus requires dialysis patients live center for a long time tends to be bulky and expensive. 传统的系统同样不够可靠,因为必须使用包括提纯系统的流体回路的无数的管子,从而增大了泄露和破坏的风险。 The traditional system is also not reliable enough, because the tube must be used, including numerous fluid circuit purification system, thereby increasing the risk of leakage and damage. 相应地,现有技术中对能够在血液透析以及血液过滤模式操作同时提供合理的便携性给患者的体外血液处理系统存在需求。 Accordingly, the prior art while providing a reasonable portability operable to hemodialysis and hemofiltration in a mode there is a need for extracorporeal blood treatment system of the patient. 这样的便携透析系统应当还有益于利用一次性部件。 Such a portable dialysis system should also be beneficial for use disposable member. 进一步地,还对这样的用于透析系统的新颖的歧管存在需求,其具有集成的血液提纯系统部件,例如传感器、泵和一次性用具以及模制的血液和透析液流动路径以避免管子的复杂网眼并提高系统稳定性。 Further, a need exists for further pipe manifold for novel dialysis system having a blood purification system integrated components, such as sensors, pumps and disposable utensils and molded blood and dialysate flow paths to avoid the tube complex meshes and improve system stability.

[0005] 传统的基于吸附剂的透析系统要求一次性透析回路的血液侧在每次治疗之前充灌消过毒的盐水,然后才允许患者血液进入回路。 [0005] Traditional dialysis system based on the requirements of the sorbent side of the disposable blood dialysis circuit recharging before each treatment and exterminated toxic brine, and then allowed to enter the patient's blood circuit. 这是重要的第一步以排空系统的任何空气。 This is an important first step in any air evacuation system. 在操作中,患者的血液进入充注有盐溶液的管子并且“驱赶”盐溶液到废物,然后开始透析。 In operation, the patient's blood into a tube filled with a saline solution and the "drive" to a waste salt solution, and then the initiation of dialysis.

[0006] 美国专利N0.4,661,246描述一种典型的单一出入口的透析仪器,其具有用于接收体液的单一导管、具有带连接到导管的流体入口和流体出口的体液侧并进一步具有带透析液入口和透析液出口的透析液侧的透析器。 [0006] U.S. Patent No. N0.4,661,246 describes a typical single doorway dialysis instrument having a single conduit for receiving a body fluid side of the fluid, having a fluid inlet and a fluid outlet connected to the duct tape and further having with dialysate inlet and a dialysate side of the dialysate outlet. 描述的透析仪器还包括用于保持包括用在透析器中的透析液的液体供应的存储装置。 Further comprising a dialysis instrument described comprises a storage means for holding the dialysate in the dialyzer with the liquid supply.

[0007] 美国专利申请N0.20020017489和美国专利N0.6,187,198描述充灌血液处理回路的系统和方法,其中不期望的气泡的留持以及污染的危险都减小。 [0007] System and method for filling hazardous blood treatment circuit of U.S. Patent Application and U.S. Patent No. N0.20020017489 N0.6,187,198 described in which leave undesirable contamination and holding bubbles are reduced.

[0008] 美国专利申请N0.20020017489提供用于在血液处理单元和患者之间的血流的动脉设置和静脉设置。 [0008] U.S. Patent Application N0.20020017489 provided for between the patient and the blood treatment unit of the artery and vein blood flow is provided. 每个设置具有以管线流动关系承载腔室的主管,和从腔室延伸以进入排放容器的支管。 Each set has a relationship between the load lock chamber competent flow line, and extending from the chamber to the manifold into the discharge vessel. 支管的一部分延伸通过腔室顶壁并凸出一段距离进入腔室中以自然产生在腔室中的液位上方的期望的操作容器的气泡。 A portion of the branch pipe extending through the chamber top wall and projecting a distance into the bubble with a desired naturally occurring in the chamber above the liquid level of the operation of the container chamber. 所述专利申请描述一种充灌方法,其通过使得充灌溶液在第一流向通过至少一个所述设置以使得充灌溶液在与血液流动通过腔室的通常方向反向的流动方向进入由所述一个设置承载的内部管路(in-line)的腔室。 The patent application describes a method of filling, such that by filling solution to flow through at least one of said first set so that the filling with the solution into the general direction of blood flow through the chamber by the flow direction is reversed a conduit disposed inside said bearer (in-line) of the chamber. 接着,优选同时执行移除从一个设置通过端口的空气并在与第一方向相反的流向通过充灌溶液,以为了完成血液处理单元的整个充灌。 Next, preferably performed simultaneously removed from a port disposed through the air flow direction and opposite to the first direction by filling a solution, that the filling is completed the whole blood treatment unit.

[0009] 美国专利申请20070185430提供用于在用于患者的肾更换治疗的单元中产生提纯的替换流体的系统和方法。 [0009] U.S. Patent Application 20070185430 provides a system and method for cell replacement therapy in a patient's kidney to produce purified replacement fluid. 所述系统能够用于提纯未提纯的流体并进一步提纯在连接过程中被污染(例如,通过接触污染)的消过毒的流体。 The system can be used to purify unpurified fluid contamination and further purified (e.g., through contact with contaminated) through the elimination of toxic fluid connection. 所述方法采用:具有膜的过滤器,所述膜具有小于待过滤的未提纯的火成的材料更小的孔尺寸,从而从清洁的侧分离过滤器的废物侧;以及与替换流体的容器流体连通的泵,所述容器与过滤器的废物侧流体连通;以及用于保持提纯的替换流体与过滤器的清洁侧流体连通的第二容器。 The method using: a filter having a membrane, the membrane having to be filtered is less than the unpurified material fumed smaller pore size, so that from the clean side of the filter separator waste side; and a replacement fluid container and means for replacing the second container in fluid communication with the filter holder of the purified fluid communication with the clean side; a pump in fluid communication with the waste side fluid communication with the filter vessel. 泵在将流体泵送出第一容器的第一方向和从血液去除废物的第二方向之间切换。 Switching between a first direction of the pump to pump fluid out of the first container and the second removal direction of the waste from the blood.

[0010] 上述所有专利和专利申请描述各种透析回路和充灌方法,并在此通过参考引入。 [0010] All of the above patents and patent applications describe various filling methods and dialysis circuit, and herein incorporated by reference.

[0011] 传统地,充灌程序要求至少一公升充灌流体例如盐水、夹子、管子、连接器和悬挂袋的柱子。 [0011] Conventionally, the program requires at least a liter of filling Filling fluid such as saline, clamps, tubing, connectors, and the bag hanging column. 患者或者保健提供者必须连接管路、打开夹子、闭合夹子并处理废物。 Patient or healthcare provider must connecting line, opening the clamp, and closing the clip processing waste. 这是一个问题,因为a)它需要高技术水平以设置和管理充灌程序,以及b)它要求额外的材料。 This is a problem because a) it needs to set the level of high-tech management and filling procedures, and b) it requires additional materials. 使用一种更方便的充灌流体源并简化充灌程序以使得不需要受过培训的保健专业人员来管理和/或处理充灌过程,这将是优选的。 Using a more convenient and simplify filling fluid source so that the filling procedure does not require trained health professionals to manage and / or treatment filling process, it will be preferable.

发明内容 SUMMARY

[0012] 本发明涉及一种能够在充灌模式和治疗模式下操作的透析治疗系统,包括:限定腔的壳体,所述腔能够容纳歧管。 [0012] The present invention relates to a dialysis system capable of operating in a filling mode and treatment mode, comprising: a housing defining a cavity, the cavity able to accommodate the manifold. 所述歧管包括:包括第一层和第二层的塑料基板;由所述第一层的第一表面和所述第二层的第一表面限定的第一流动路径;由所述第一层的第一表面和所述第二层的第一表面限定的第二流动路径;以及与所述第一流动路径和所述第二流动路径都流体连通的阀,其中所述阀具有第一状态和第二状态,其中当处于所述第一状态时,所述第一流动路径和第二流动路径流体隔离,当处于所述第二状态时,所述第一流动路径和第二流动路径流体连通;以及物理附着到所述壳体的阀接口,其中所述阀接口配置为传输信号到所述阀以使得所述阀在所述第一状态和所述第二状态之间切换。 Said manifold comprising: a plastic substrate comprising a first layer and a second layer; defined by the first surface of the first layer and the first surface of the second layer of the first flow path; by the first a first surface layer and the first surface of the second layer defines a second flow path; and said first flow path and the second flow path are in fluid communication with a valve, wherein the valve has a first state and a second state, wherein when in said first state, said first flow path and second flow paths fluidly isolated when in said second state, said first flow path and second flow path fluid communication; and physically attached to the interface of the valve housing, wherein the valve interface configured to transmit a signal to the valve so that the valve is switched between the first state and the second state.

[0013] 任选地,歧管进一步包括:第一泵出口,其中所述第一泵出口接收通过第一泵泵送的血液;和第二泵出口,其中第二泵出口接收通过第二泵泵送的透析液。 [0013] Optionally, the manifold further comprises: a first pump outlet, wherein the outlet of the first pump receives a first pump through a blood pump; and a second pump outlet, wherein the outlet of the second pump by a second pump receiving dialysate pumped. 任选地,阀定位为与所述第一泵出口和所述第二泵出口相邻。 Optionally, the valve is positioned adjacent to the outlet of the first pump and the second pump outlet. 任选地,阀处于所述第一状态,第一泵出口和第二泵出口彼此流体隔离。 Optionally, the valve is in the first state, a first outlet and a second pump pumps a fluid outlet isolated from one another. 任选地,当阀处于所述第二状态时,第一泵出口和第二泵出口彼此流体连通。 Optionally, when the valve is in the second state, the first pump and the second pump outlet fluid communication with each outlet. 任选地,透析治疗系统进一步包括控制器,其中所述控制器产生信号以使得所述阀在所述第一状态和所述第二状态之间切换。 Optionally, a dialysis treatment system further comprises a controller, wherein the controller generates a signal to the valve such that the switching between the first state and the second state. 在一个实施例中,控制器产生信号以响应透析治疗系统在充灌模式操作的命令使得所述阀从所述第一状态切换到所述第二状态。 In one embodiment, the controller generates a command signal in response to dialysis treatment in the system mode of operation such that the filling valve is switched from the first state to the second state. 在另一个实施例中,控制器产生信号以响应透析治疗系统在治疗模式操作的命令使得所述阀从所述第二状态切换为所述第一状态。 In another embodiment, the controller generates a command signal in response to dialysis treatment in a treatment mode of operation of the system such that the valve is switched to the first state from the second state. 透析治疗系统进一步包括透析液储存器,所述歧管的充灌通过利用来自所述透析液储存器而不是来自单独的充灌流体源的透析液实实施。 The system further comprises a dialysis treatment dialysate reservoir, said filling manifold by using real embodiment dialysate from the dialysate reservoir, rather than from a separate source of fluid filling.

[0014] 在另一个实施例中,本发明涉及能够在充灌模式和治疗模式操作的歧管,包括:包括第一层和第二层的塑料基板;由所述第一层的第一表面和所述第二层的第一表面限定的第一流动回路;由所述第一层的第一表面和所述第二层的第一表面限定的第二流动回路;与所述第一流动回路和所述第二流动回路都流体连通的阀,其中所述阀具有第一状态和第二状态,当处于所述第一状态时,来自所述第一流动回路的流体不能进入所述第二流体回路,当处于所述第二状态时,来自所述第一流动回路的流体可以进入所述第二流动回路;以及接收来自信号源的信号以使得所述阀在所述第一状态和所述第二状态之间切换的接口。 [0014] In another embodiment, the present invention relates to a manifold capable of operating in a filling mode and treatment mode, comprising: a plastic substrate comprising a first layer and a second layer; by the first surface of the first layer and said second layer first surface defining a first flow circuit; defined by the first surface of the first layer and the first surface of the second layer of the second flow circuit; and the first flow circuit and the second flow circuit are in fluid communication with a valve, wherein the valve has a first state and a second state, when in the first state, fluid from the first flow circuit can not enter the first two fluid circuits, when in the second state, fluid from the first flow circuit may flow into the second loop; and receiving a signal from a signal source such that the valve is in the first state and the switching state between the second interface.

[0015] 任选地,接口响应在充灌模式操作的信号使得所述阀从所述第一状态切换到所述第二状态。 [0015] Optionally, the interface signal in response to a mode of operation such that the filling valve is switched from the first state to the second state. 任选地,接口响应在治疗模式操作的信号使得所述阀从所述第一状态切换到所述第二状态。 Optionally, the interface signal in response to the treatment mode of operation such that the valve is switched from the first state to the second state.

[0016] 在另一个实施例中,本发明涉及用于充灌用于透析治疗中的透析设备内的歧管的充灌方法,包括步骤:a)将所述歧管插入到所述透析设备中,其中所述歧管包括每个由基板限定的血液回路和透析液回路,以及与所述血液回路和透析液回路的每个流体连通的阀,其中所述阀具有第一状态和第二状态,并且其中当处于所述第一状态时,来自所述透析液回路的流体不能进入所述血液回路,当处于所述第二状态时,来自所述透析液回路的流体能够进入到所述血液回路中山)布置所述阀在所述第二状态中;c)泵送透析液通过所述血液回路;d)布置所述阀在所述第一状态;以及e)从所述血液移除透析液。 [0016] In another embodiment, the present invention relates to a method for filling a filling manifold in the dialysis machine during dialysis treatment, comprising the steps of: a) inserting a manifold into the dialysis apparatus in which each said manifold comprising a substrate defined by a blood circuit and a dialysate circuit, and the valve and the blood circuit and the dialysate circuit of each of the fluid communication, wherein the valve has a first state and a second state, and wherein when in the first state, fluid from the dialysate circuit can not enter the blood circuit, when in the second state, fluid from the dialysate circuit is able to enter into the Zhongshan blood circuit) of the valve disposed in said second state; c) pumping the dialysate through the blood circuit; D) of the valve disposed in the first state;) is removed from the blood and e dialysate.

[0017] 任选地,透析液从透析液储存器而非从充灌流体的单独的源泵送。 [0017] Optionally, the dialysate from the dialysate reservoir, rather than from a separate source of fluid filling pump. 任选地阀通过与来自位于透析设备内的控制器的信号通信而布置在所述第一状态或者第二状态。 Optionally, the communication signal from the controller via a valve located within the dialysis machine and arranged in the first state or the second state.

附图说明 BRIEF DESCRIPTION

[0018] 本发明的这些以及其它特征和优点将被认识到,因为当相对于附图进行考虑时参照下面的详细描述它们变得更好地得以理解。 [0018] These and other features and advantages of the invention will be appreciated that, as with respect to the accompanying drawings, when considered with reference to the following detailed description, they become better understood.

[0019] 图1示出用于体外血液处理系统的示例性流体回路; [0019] FIG. 1 shows an exemplary fluid circuit for extracorporeal blood treatment system;

[0020]图2示出根据本发明的一个实施例的示例性的紧凑歧管的结构元件; [0020] FIG 2 illustrates an exemplary compact manifold member of the present invention according to one embodiment;

[0021] 图3a提供紧凑歧管的中间的主体部件的透视图; [0021] FIG. 3a of the intermediate body member to provide a compact perspective view of the manifold;

[0022]图3b提供具有示例性尺度的紧凑歧管的中间的主体部件的透视图; [0022] Figure 3b provides a perspective view of an intermediate body member having a compact manifold tube exemplary dimensions;

[0023]图4是详细描述根据本发明的一个实施例的紧凑歧管的流体回路的示意图; [0023] FIG. 4 is a schematic fluid circuit in a compact manifold tube embodiment of the present invention in detail;

[0024] 图5示出紧凑歧管内的示例性的电导率单元; [0024] FIG 5 illustrates an exemplary cell conductivity within a compact manifold;

[0025] 图6a示出根据本发明的一个实施例的体外血液处理系统,具有集成到用于确定系统的操作模式的紧凑歧管中的两个双路(two-way)阀; [0025] Figure 6a illustrates a extracorporeal blood treatment system according to one embodiment of the present invention, integrated into a compact having a manifold system for operating mode determination in the two-way (two-way) valve;

[0026] 图6b示出根据本发明的一个实施例的血液透析/血液过滤回路的进一步的细 [0026] Figure 6b shows a further fine filter circuit according to a hemodialysis embodiment of the present invention embodiment / blood

-K- -K-

T ; T;

[0027] 图6c示出本发明的配置为在血液透析模式操作的体外血液处理系统的分解视图; [0027] Figure 6c shows a configuration of the present invention is an extracorporeal blood treatment system in hemodialysis mode of operation of an exploded view;

[0028] 图6d示出其中本发明的体外血液处理系统配置为早血液过滤治疗方案下的实施例; [0028] Figure 6d shows an embodiment wherein the extracorporeal blood treatment system of the present invention is configured to early blood filtration treatment programs;

[0029]图6e示出其中紧凑歧管包括仅一个双路阀以确定系统的操作模式的另一实施例。 [0029] Figure 6e illustrates a compact wherein the manifold includes a two-way valve only to determine the mode of operation of another embodiment of a system.

[0030] 图7示出其中血液和透析液回路是完全一次性的,预装有透析器,并预包装在带有紧凑歧管的套件中的实施例; [0030] FIG. 7 shows an example in which the blood and the dialysate circuit is fully disposable, pre-dialyzer, and embodiments set with a compact manifold prepackaged;

[0031]图8示出紧凑歧管在便携透析系统中的安装; [0031] FIG. 8 illustrates a compact manifold mounted in the portable dialysis system;

[0032]图9示出具有成功安装的歧管的便携透析系统的另一个视图; [0032] FIG. 9 shows another view of the portable dialysis system having a manifold of a successful installation;

[0033] 图10是示出在透析模式中的本发明的一个实施例的示意性图形;和 [0033] FIG. 10 is an exemplary graphical diagram illustrating an embodiment of the present invention in a dialysis mode; and

[0034]图11是示出在透析充灌模式中的本发明的一个实施例的示意性图形。 [0034] FIG. 11 is a diagram illustrating the present invention in a filling mode dialysis exemplary graphical embodiment.

具体实施方式 Detailed ways

[0035] 尽管本发明可以以许多不同形式进行实施,但是为了便于理解本发明的原理,现参照在附图中示出的实施例并且特定的语言将用于描述所述实施例。 [0035] Although the present invention may be embodied in many different forms, but in order to facilitate an understanding of the principles of the present invention, Referring now to the embodiment illustrated in the drawings and specific language will be used to describe the same. 然而,应当理解,并不打算因此限制本发明的范围。 However, it should be appreciated, therefore not intended to limit the scope of the present invention. 本发明所涉及的技术领域的技术人员通常能够想到的在描述的实施例中的任何变化和进一步修改以及如在此描述的本发明的原理的任何的进一步应用。 Any further applications of the present invention is generally skilled in the art can be occur in principle in the embodiment and any further variations and modifications of the present invention as described herein are described.

[0036] “治疗”、“处理”及其变体是指与病情相关的一个或多个症状或者体症的程度、频率或者严重性的任何降低。 [0036] "treating", "treatment" and variations thereof refers to the degree of the disease associated with one or more symptoms of disease or bodies, any reduction in the frequency or severity.

[0037] “持续时间”及其变体是指从开始到结束的规定治疗的时间段,不管治疗是否因为病情治愈而结束或者治疗由于任何原因而中止。 [0037] "duration" and variations thereof refers to the period from the beginning to the end of the prescribed treatment, regardless of whether the treatment is to cure the disease because the treatment ended or suspended for any reason. 在治疗的持续时间中,可以规定多个治疗疗程,在所述疗程中对对象执行一个或多个规定的刺激。 The duration of treatment may be prescribed multiple treatment sessions, one or more of a predetermined object in the course of the stimulation.

[0038] “疗程”是指作为规定的治疗计划的一部分对对象执行一剂刺激的时间。 [0038] A "course" refers to a predetermined time as part of treatment planning is performed on a target stimulus.

[0039] 术语“和/或”是指所列要素的一个或者全部,或者所列要素的任何两个或多个的组合。 [0039] The term "and / or" refers to a combination of any two or more of one or all of the listed elements or the listed elements.

[0040] 术语“包括”及其变体在出现在说明书和权利要求中的情形下并不具有限制的含义。 [0040] The term "comprising" means in the context of its variants appear in the description and the claims does not have limitations.

[0041] 除非另有特别说明,“一”、“所述”、“一个或多个”和“至少一个”是可互换使用的并且指一个或超过一个。 [0041] Unless otherwise specified, "a", "the", "one or more" and refer to one or more than one, and "at least one" are used interchangeably.

[0042] 对于包括离散的步骤的在这里公开的任何的方法,所述步骤可以以任何可行的顺序执行。 [0042] For any discrete method comprising the steps of disclosed herein, the steps may be performed in any feasible order. 并且,根据需要,两个或多个步骤的任何组合可以同时执行。 And, if necessary, any combination of two or more steps may be performed simultaneously.

[0043]同样地,在这里,通过端点的数值范围的引用包括包含在该范围内的所有数字(例如,I至5包括1、1.5、2、2.75,3,3.80、4、5等)。 [0043] Similarly, where reference includes all numbers subsumed within that range of numerical ranges by endpoints (e.g., I-5, 3.80, 4, etc.). 除非另有特别说明,在说明书和权利要求中使用的表示部件数量、分子重量等的所有数字应当理解为在所有情形下都可以被术语“大约”修饰。 All figures unless specifically stated otherwise, indicates the number of parts used in the specification and the claims, molecular weight, etc. as can be understood by the term "about" in all instances. 相应地,除非另有相反说明,在说明书和权利要求中提出的数字参数都是近似值,其可以取决于本发明寻求获得的期望属性而变化。 Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and claims are approximations that may depend on the present invention seeks to obtain a desired property change. 最起码,并且不是试图限制权利要求的范围的等同原则,每个数字参数应当至少根据所代表的明显的位数以及进行普通的取整技术进行理解。 The very least, and not intended to limit the scope of the doctrine of equivalents of the claims, each numerical parameter should at least be represented by significant digits and ordinary rounding techniques will be understood.

[0044] 尽管阐明本发明的宽的范围的数值范围和参数是近似值,但是在特定例子中提出的数字值被尽可能精确地汇报。 [0044] Notwithstanding that the numerical ranges and parameters of the broad scope of the present invention are approximations, the digital values ​​set forth in the specific examples are reported as precisely as possible. 但是,全部的数字值固有地包含在它们的各测试测量中发现的标准偏差所导致的必要的一定范围。 However, all numerical values ​​inherently contain the necessary range of the standard deviation found in their respective testing measurements caused.

[0045] 本发明消除了对具有消过毒的盐水的单独的包以及它的相关硬件的需要。 [0045] The present invention eliminates the need for having a separate package of sterile saline and its associated hardware. 在一个实施例中,本发明采用吸附剂产生的透析液,其在当回路的透析液侧被充灌时产生,作为用于血液侧的充灌流体。 In one embodiment, the present invention employs an adsorbent to produce a dialysate, which is generated when filling the dialysate side of the circuit when, as a fluid for filling the blood side. 为了解释本发明的目的,本发明的充灌方法和系统中的示例性歧管将首先被描述。 Purposes of explaining the present invention, a method and filling system of the present invention in an exemplary manifold will be described first.

[0046] 图1示出用于体外血液处理系统100的流体回路,其用于进行血液透析和血液过滤。 [0046] Figure 1 shows a fluid circuit for extracorporeal blood treatment system 100, which is used for hemodialysis and hemofiltration. 在本发明的一个实施例中,系统100实施为便携人工肾(PAK),其可以由患者使用来在家里进行透析。 In one embodiment of the present invention, system 100 is implemented as a portable artificial kidney (PAK), which can be used by a patient at home dialysis.

[0047] 参照图1,血液透析系统包括两个回路-血液回路101和透析液回路102。 [0047] Referring to FIG 1, a hemodialysis system comprising two loops - the blood circuit and the dialysate circuit 101 102. 在透析过程中的血液治疗通过具有半透膜的交换器-血液透析器或者透析器103引入体外循环。 Treatment of blood during dialysis by a semipermeable membrane exchanger having a - or introduced into the extracorporeal hemodialysis dialyzer 103. 患者的血液在膜(透析器)103的一侧上在血液回路101中循环,称作透析液的透析液体,其包括由医师规定浓度的血液的主电解液,在透析液回路102另侧上循环。 The patient's blood is circulated on one side of the membrane 103 (dialyzer) in the blood circuit 101, referred to as dialysate of the dialysis liquid, comprising a main electrolyte concentration in blood by the physician prescribed, on the other side of the dialysate circuit 102 cycle. 这样,透析液流体的循环提供用于血液中的电解浓度的调整和调节。 Thus, the dialysate fluid circulation provides for adjusting the concentration in the blood of electrolysis and regulation.

[0048] 在血液回路101中馈送不纯的血液到透析器103的来自患者的线路104设置有梗塞检测器105,其整体地连接到目视或者音响警报(未示出)以发出对血液流动的任何阻塞的信号。 [0048] In the blood circuit 101 is fed to the dialyzer impure blood line 104 from a patient 103 is provided with a infarct detector 105, which is integrally connected to a visual or audible alarm (not shown) to issue a flow of blood any signal blocked. 为了防止血液凝结,用于注射抗凝剂例如肝素到血液中的装置106,例如泵、注射器或者任何其它的注射装置,同样被提供。 To prevent blood clotting, such as heparin, for injecting an anticoagulant to the blood in the device 106, such as a pump, a syringe or any other injection device, it is likewise provided. 还提供蠕动泵107以保证血液在正常(期望)方向的流动。 A peristaltic pump 107 is also provided to ensure normal blood flow in the (desired) direction.

[0049] 压力传感器108设置在不纯的血液进入透析器103的入口处。 [0049] The pressure sensor 108 is provided at the inlet of the blood entering the dialyzer 103 impure. 其它压力传感器109、110、111和112设置在血液透析系统的各个位置,其帮助跟踪和保持在优势点的流体压力。 Other pressure sensors 109, 110 at various locations and hemodialysis system, which help track and held in fluid pressure vantage point 112 is provided.

[0050] 在来自透析器103的使用过的透析液流体进入透析液回路102的点上,血液泄漏传感器113被提供以传感和警告到透析液回路中的任何血细胞泄漏。 [0050] At the point from the dialyzer dialysate fluid 103 enters the used dialysate circuit 102, the blood leak sensor 113 is provided to sense and to alert any leakage of blood cell in the dialysate circuit. 一对旁通阀114同样提供在透析液回路的起点和终点,以使得在起动情形下,或者操作者认为需要的其它情形下,透析器可以由透析液流体流动绕过,但是流动仍得以维持。 One pair of bypass valve 114 is also provided at the start and end of the dialysate circuit, so that the start-up situation, an operator or other situations that require the dialyzer dialysate can be bypassed by the fluid flow, but the flow is still maintained . 另一个阀115正好设置在充灌/排出端口116之前。 Another valve 115 is provided just before the filling / discharge port 116. 端口116用于通过透析液溶液初始充注回路,并在透析后以及在一些情形下在透析过程中移除使用过的透析液流体。 Port 116 for initially filling the dialysate circuit through the solution, and the dialysis fluid and the dialysate removed in some cases used in the dialysis process. 在透析过程中,阀115可以用于通过再次补充适当浓度的流体而更换掉用过的例如高浓度的钠透析液的一部分,以使得透析液的总的组分浓度保持在期望水平。 During dialysis, valve 115 may be used, for example, part of the spent dialysate sodium concentration higher by an appropriate concentration of added again to replace the lost fluid, so that the total dialysate component concentrations at a desired level.

[0051] 透析液回路设置有两个蠕动泵117和118。 [0051] The dialysate circuit is provided with two peristaltic pumps 117 and 118. 泵117用于泵送透析液流体到排出或者废物容器,以及用于泵送再生的透析液到透析器103中。 A pump 117 for pumping the dialysate fluid to or discharging waste container, and the dialysate to the dialyzer 103 for pumping the regeneration. 泵118用于从透析器103泵送出用过的透析液,并通过吸附剂119对其施压,以及用于泵送入来自端口116的透析流体,用于充填系统或者维持透析液中的组分浓度。 Pump 118 for pumping the spent dialysate from the dialyzer 103, and 119 apply pressure through the adsorbent, and means for feeding the dialysis fluid from the pump port 116 for filling the system or maintained in the dialysate component concentrations.

[0052] 吸附剂类型的盒119设置在透析液回路中,其包含数层材料,每层具有移除杂质例如尿素和肌氨酸酐的特定作用。 [0052] The sorbent cartridge 119 of the type provided in the dialysate circuit, which comprises several layers, each layer having a specific role to remove impurities such as urea and creatinine. 这些材料的组合允许适于饮用的水充入到系统中,用作透析液流体。 Combinations of these materials allows the potable water charged to the system, as the dialysate fluid. 还允许闭合环透析。 Also allows a closed loop dialysis. 也就是,吸附剂盒使得能够从来自透析器的用过的透析液再生新的透析液。 That is, the sorbent cartridge can be reproduced so that the new dialysate from the spent dialysate from the dialyzer. 对于新的透析液流体,适当容量例如0.5、1、5、8或者10公升的衬里容器或者储存器120被提供。 For new dialysate fluid, e.g. 0.5,1,5,8 suitably sized liner or 10 liter container or reservoir 120 is provided.

[0053] 取决于基于医师处方的患者要求,期望量的注入液溶液121可以加入到透析流体中。 [0053] depends on the patient prescription requirements, the desired amount of infusate solution 121 may be added to the dialysis fluid. 注入液121是包含矿物质和/或葡萄糖的溶液,其帮助在吸附剂进行的不期望的移除之后补充透析液流体中的例如钾和钙的矿物质到适当水平。 121 infusate containing minerals and / or glucose solution, which helps to remove the undesired conducted in the adsorbent mineral supplements dialysate fluid e.g. potassium and calcium to an appropriate level after. 提供蠕动泵122以泵送期望量的注入液溶液到容器120。 Providing a peristaltic pump 122 to pump the desired amount of the solution was injected into the liquid container 120. 照相机123可以任选地提供来监测注入液的不断改变的液位,作为注入液流动失效的安全检查警告。 The camera 123 may optionally be provided to monitor the changing level of liquid injection, an injection liquid, the flow checks fail safety warnings.

[0054] 提供加热器124以保持容器120中的透析液流体的温度在要求的水平。 [0054] The heater 124 provided to maintain the temperature of the dialysate fluid level in the container 120 in the claims. 透析液流体的温度可以由正好位于流体进入透析器的入口之前的温度传感器125进行传感。 The temperature of the dialysate fluid may enter the fluid located just prior to the dialyzer inlet temperature sensor 125 for sensing. 容器120同样装备有:刻度尺126,用于跟踪容器中流体的重量以及由此的体积;以及电导传感器127,其显示透析液流体的电导率。 Container also equipped with a 120: 126 scale for tracking fluid in the container weight and volume thereby; and a conductivity sensor 127, which shows the conductivity of the dialysate fluid. 电导传感器127提供透析液中钠水平的指示。 Dialysate conductivity sensor 127 provides an indication of the level of sodium.

[0055] 在来自患者的血液进入到用于透析的系统之前,提供医疗端口129。 [0055] Before the blood from the patient into the dialysis system for providing medical port 129. 在来自透析器的清洁的血液返回到患者之前提供另一医疗端口130。 In a clean blood from the dialyzer before the patient returns to provide another medical port 130. 空气(或者气泡)传感器131和弹簧夹132用于回路中以检测和防止任何空气、其它或者气泡返回到患者。 Air (or air bubbles) and a spring clip 132 for sensor 131 to detect and prevent any air, or other gas bubbles to the patient return circuit.

[0056] 充灌装置133附连到血液透析系统,其通过在其用于透析之前用消毒盐水充注血液回路而帮助准备该系统。 [0056] The recharging device 133 is attached to the hemodialysis system, prior to its use by dialysis filled with sterile saline and help prepare the blood circuit system. 充灌装置可包括具有IV袋钉或者IV针或者预附连的二者的组合的短管部分。 Recharging means may comprise a staple IV bag or IV needle or pre-combined short tube portion attached both.

[0057] 本领域技术人员从上面关于用于血液透析的流体回路的讨论可以得出,血液透析和/或血液过滤系统是一种复杂的系统并包括数个元件。 [0057] Those skilled in the art can draw from the above discussion for the fluid circuit of the hemodialysis, hemodialysis and / or hemofiltration system is a complex system and includes several elements. 如果以传统的方式实施,该系统将呈现为管网,并且对于家庭透析用户来说配置和使用过于复杂。 If implemented in a conventional manner, the system will be presented as a pipe network, and configure and use too complicated for home dialysis users.

[0058]因此,为了制造简单且易于患者在家中使用的系统,本发明实施系统为紧凑的歧管,其中如图1所示的流体回路的大部分部件集成为一件模制塑料或者配置为连接在一起以形成单一的操作歧管结构的多件模制塑料。 [0058] Accordingly, in order to manufacture most simple and easy system to use in a patient at home, a compact embodiment of the system of the present invention a manifold, wherein the fluid circuit means shown in FIG. 1 integrated into a molded plastic or as They are joined together to form a single multi-piece plastic molding operation of the manifold structure.

[0059] 图2示出根据本发明的一个实施例的紧凑歧管的结构元件。 [0059] FIG. 2 shows the structure of a compact manifold element embodiment in accordance with one embodiment of the tube of the present invention. 一次性歧管泵送和导向流体流动,同时测量关键区域的压力。 Disposable pumping manifold and the fluid flow guide, while the critical pressure of the measurement region. 这些流体包括血液、透析液、注入液和抗凝剂。 These fluids include blood, dialysate, and anticoagulant fluid injection. 此夕卜,歧管提供用于检测血液从透析器泄露的特征、用于检测动脉线路中的梗塞的特征和用于检测静脉线路中的空气的特征。 Bu this evening, the manifold is provided for detecting leakage of blood from the dialyzer feature for feature detection of the arterial line of the infarct and for detecting features of the air in the venous line.

[0060] 参照图2,在一个实施例中,紧凑歧管200包括具有固定地附连在那里的部件的多个塑料层。 [0060] Referring to Figure 2, in one embodiment, the compact 200 includes a manifold having a plurality of plastic layers fixedly member attached there. 更具体地,歧管200包括以下元件: More specifically, the manifold 200 includes the following elements:

[0061]后盖 201 [0061] The rear cover 201

[0062] 压力传感器膜202 [0062] The pressure sensor diaphragm 202

[0063]阀膜 203 [0063] The valve membrane 203

[0064] 中间主体204 [0064] The intermediate body 204

[0065]前盖 205 [0065] The front cover 205

[0066] 泵管部分(图2中未示出) [0066] The tubing section (not shown in FIG. 2)

[0067] 中间主体层204模制包含在一侧上的通道中。 [0067] 204 intermediate layer molded body comprising the channels on one side. 这些通道借助包括超声波焊接的许多方法通过固定地附着到中间主体的前盖层实现。 These channels are achieved by the cover layer is fixedly attached to the front of the intermediate body by means of a number of methods including ultrasonic welding. 该组合的前盖-中间主体结构形成歧管内的流体通路的主要部分。 The combination of the front cover - middle part of the main structure of the main fluid passage is formed within the manifold. 在中间主体204的相对侧上具有形成用于阀和压力传感的表面的特征,其连通到歧管前盖侧面上的流体通路。 Characterized in having a forming surface for the valve and a pressure sensor on the opposite side of the intermediate body 204 which communicates with the fluid passage on the front side of the manifold cover. 歧管包括用于阀和压力传感的弹性部件。 The manifold includes an elastic member for the valve and the pressure sensing. 这些弹性部件通过利用超声波焊接而收纳在后盖层和中间主体层之间,并且实现遍及歧管的流体通路。 These elastic member housed between the cover layer and the intermediate layer is formed by the body by ultrasonic welding, to achieve across the fluid passage and the manifold.

[0068] 参照图2,在一个实施例中,歧管200包括五个压力传感器膜202和三到四个用于双路阀的膜203。 [0068] Referring to Figure 2, in one embodiment, the manifold 200 includes five pressure sensor film 202 and the film 203 for three to four two-way valves. 在一个实施例中,两个盖201和205以及歧管200的中间主体204由聚碳酸酯材料或者ABS (丙烯腈丁二烯苯乙烯)模制而成。 In one embodiment, the two intermediate cover 201 and the body 205 and a manifold 200, 204 of a polycarbonate material or ABS (acrylonitrile butadiene styrene) molded. 压力传感器膜202和阀膜203由普通材料例如Santoprene,或者更优选地Sarl ink,模制而成,所述材料为医学级弹性聚合物。 Pressure sensor diaphragm 202 and diaphragm 203 e.g. Santoprene, or more preferably Sarl ink from a common material, molded, the elastomeric material is a medical grade polymer. 在一个实施例中,前盖和后盖205和201可以由光学透明材料,至少对某些预选波长的光透明的材料,模制而成,以允许对包含在里面的流体进行光谱分析。 In one embodiment, the front and rear covers 205 and 201 may be made of optically transparent material, at least some of the material transparent to light of a preselected wavelength, molded, to allow the fluid contained in it for spectral analysis.

[0069] 此外,该歧管优选地包括四个泵送部件。 [0069] In addition, the manifold preferably comprises four pumping member. 这些泵送部件是挤压成型的PVC管子的部分,其形成为并且尺度适合以具有优化用于泵用途,特别是滚子泵用途的属性。 The pumping member is part of extruded PVC tube which is formed and dimensioned to pump having optimized for use, in particular a roller pump use properties. 该管子接合到具有倒钩的配置,所述配置一体模制到歧管中间主体。 The tube is joined to a barbed configuration, the configuration is integrally molded to an intermediate manifold body. 四个泵送部件的一个用于从患者的动脉抽取血液并将其泵送通过透析器以及回到患者的静脉。 Four pumping member for withdrawing blood and pumped through the dialyzer and the venous return to the patient from the patient's artery. 两个泵送部件是用于透析液流动,以及一个是用于将注入液递送到透析液流体回路。 Two means for pumping dialysate flow, and injecting a liquid for delivery to the dialysate fluid circuit. 单独的注射器泵可以用于在透析器之前泵送抗凝血剂到动脉血液通路中。 Individual syringe pump may be used to pump anticoagulant into the arterial blood circuit prior to the dialyzer.

[0070] 在一个实施例中,歧管进一步包括管子端口,优选地是在10-14个的范围,更优选12个端口,用于连接歧管内的所有流体通路到包括透析器、吸附剂盒、袋储存器、注入液容器、患者血液线路、抗凝血剂、传感器、充灌线路和排出线路的一次性装置中的其它的部件,如下面进一步讨论的。 [0070] In one embodiment, the manifold further comprises a tube port, preferably in the range of 10 to 14, more preferably 12 ports for connecting all of the fluid within the manifold passage to the dialyzer, sorbent cartridge , storage bags, infusate containers, patient blood line, anticoagulants, sensors, lines and filling lines discharging disposable device of the other components, as discussed further below.

[0071 ] 在一个实施例中,歧管成形为大写的“ I ”,具有彼此平行的第一部分和第二部分以及连接部分,该连接部分a)垂直于第一部分和第二部分,并且b)用于连接第一和第二部分。 [0071] In one embodiment, the manifold is formed uppercase "I", parallel to each other having first and second portions and a connecting portion, the connecting part a) in a first portion and a second vertical portion, and b) for connecting the first and second portions. 在一个实施例中,连接部分连接第一部分的中央到第二部分的中央,从而使得连接部分和第一和第二部分的每个末端之间的距离为等距离的。 In one embodiment, a first connecting portion connecting the central portion to the center of the second portion, so that the distance between the connecting portion and each end portion of the first and second equidistant. 应当认识到,连接部分可以布置在第一和第二部分的末端上,从而形成大写的“C”或者向后的“C”。 It should be appreciated that the connecting portion may be disposed on the ends of the first and second portions, thereby forming a capital "C" or rearward "C". 歧管还可以相对于透析系统旋转,并且不必定位为大写的“I”,例如,它可以定位在它的侧面上或者成一定角度。 The manifold may further rotation relative to the dialysis system, and need not be positioned as a capital "I", e.g., it may be positioned on its side or at an angle. 如图3b所示,在示例性实施例中,歧管具有以下尺度:L1和L2是在4-7英寸范围内,优选大约5.7英寸,L3和L4是在0.5-1.5英寸范围内,优选大约I英寸,L5是在2.5-4.5英寸的范围,优选大约3.5英寸,L6是在1-3英寸的范围内,优选大约1.8英寸。 3b, in an exemplary embodiment, manifold has the following dimensions: L1 and L2 are within the range of 4-7 inches, preferably about 5.7 inches, L3 and L4 is in the range of 0.5 to 1.5 inches, preferably about I inches, L5 in the range of 2.5 to 4.5 inches, preferably about 3.5 inches, L6 is in the range of 1-3 inches, preferably about 1.8 inches. 尽管已经提供了上述尺度,但是应当认识到,在此公开的本发明并不限于任何特定尺度或者尺度的组合。 Although the above has provided dimensions, it will be appreciated that the invention disclosed herein is not limited to any particular dimension or combination of dimensions.

[0072] 在一个实施例中,歧管200的装配工艺包括配合后盖201到中间主体204,同时通过使得膜的第一侧面物理地附着或者接触中间主体以及使得膜的第二侧面通过后盖201中的孔、空间或者空穴211而将膜202和203贴附就位。 [0072] In one embodiment, the manifold assembly process 200 includes back cover 201 fitted to the intermediate body 204, while the intermediate body attached to or in contact with a second side surface, and that the film so that the film through the first side cover by physically 201 holes, spaces or holes 211 and 203 attached to the film 202 in place. 优选地,膜的第二侧面具有层级结构,其允许第一层级通过空穴211,而第二层级保留在后盖201和中间主体204之间。 Preferably, the second side of the film has a hierarchical structure that allows a first level through hole 211, while the second level remains between the cover 201 and the intermediate body 204. 这贴附膜202、203到后盖201中。 This film is attached to the rear cover 202, 203, 201. 而且,优选地,中间主体204包含凹陷,膜202、203的第一侧面位于该凹陷中,从而将它们贴附到中间主体204。 Also, preferably, the intermediate body comprises a recess 204, first side membrane 202, 203 located in the recess, so that the intermediate body 204 is attached to them. 在替代的构型中,膜202和203可以以多射击模制工艺共模制到后盖201。 In an alternative configuration, the film 202 and 203 may be a multi-shot molding process is co-molded to the back cover 201.

[0073] 本领域技术人员将认识到,歧管的各个部件可以利用任何适当的装置边界接合或者固定在一起。 [0073] Those skilled in the art will recognize that the various components of the manifold may be joined or secured together by any suitable means boundaries. 在一些实施例中,中间主体和后盖之间的密封经由超声波焊接或者胶粘剂实现。 In some embodiments, the seal between the intermediate body and the rear achieved via ultrasonic welding or adhesive. 替代地,可以采用激光焊接。 Alternatively, laser welding may be employed. 前盖以类似的方式接合到中间主体的另一侧面。 The other side of the front cover engages in a similar manner to the intermediate body. 在一个实施例中泵管子部分溶剂接合就位,或者在替代实施例中,可以利用塑料中的吸收激光的添加剂对所述部分进行激光焊接。 Laser welded portion of the additive in the solvent embodiment of the pump tube portion is bonded in place one embodiment, or in alternative embodiments may be utilized in the plastic absorbs laser light.

[0074] 在一个实施例中,前盖由透明的并且将提供对流体通路的可见性的BASF Terlux2802HD,ABS模制而成。 [0074] In one embodiment, a transparent front cover and provides visibility BASF Terlux2802HD fluid passage, ABS molded. ABS的透明性同样提供一种用于检查超声波焊接的表面的完整性的手段。 Transparency of ABS also provides a means for checking the integrity of the surface for ultrasonic welding. ABS由于其生物相容性以及对超声波焊接的兼容性而是优选的。 ABS due to its biocompatibility and compatibility of ultrasonic welding are preferred. 此外,前盖可以包括模制在里面的纹理表面以帮助促进前盖和中间主体之间更好地接合。 Further, the front cover may include a textured surface molded inside to help facilitate better engagement between the front cover and the intermediate body. 该纹理表面是一种本领域技术人员知晓的化学蚀刻工艺。 The textured surface is a known to those skilled in the chemical etching process. 一个优选的纹理深度为.0045”。其它适当的纹理也可以是激光蚀刻的。待焊接在前盖上的表面设计为具有.003”的凹陷,其转换为在模具上的.003”的升高表面。这提供精确的表面以接收纹理。一旦在模具上产生纹理,该.003”表面的高度降低。 A preferred depth of the texture is .0045 ". Other suitable texture may be laser-etched. To be welded to the front surface of the cover is designed to have a .003" depression, converted on the mold .003 "liter high surface. this provides accurate surface. Once the texture on the mold to receive the texture, the .003 "surface height reduction. 因为.0045”纹理深度的峰和谷,可以假定,平均值将是所述数量的一半或者.00225”。 Because .0045 "depth of the texture of peaks and valleys, can be assumed to be the average number of half or .00225." 该结果将使得模具处于.00075”的钢安全条件中。 The result will be such that the mold is in .00075 "steel safe conditions.

[0075] 在一个实施例中,前盖提供动脉和静脉通路中的血流导向器。 [0075] In one embodiment, the front cover to provide arterial and venous blood guide passage. 这些特征设计来最小化溶血。 These features are designed to minimize hemolysis. 血流导向器提供用于整个通路中的始终如一的横截面积并最小化如果没有导向器的存在血液将接触到的锋利边缘。 Blood flow cross-sectional area provided for the entire guide path and minimize consistently without the presence of blood in the guide will be exposed to the sharp edges. 在血流导向器的相对侧面上的壁已经被用于提供模制塑料部分中的更加均一的壁厚度。 Walls on opposite sides of the blood flow guides have been used to provide a more uniform wall thickness of the molded plastic portion. 这将防止在这个区域的沉孔,而沉孔会影响周围的焊接表面。 This will prevent the counterbore region, can affect the counterbore surface around the weld. 在一个实施例中,前盖壁厚度是.075”。 In one embodiment, the front cover wall thickness is .075. "

[0076] 任选地,前盖具有用于组装目的而设置的对齐孔,以保证在超声波焊接工艺过程中前盖和中间主体的精确对齐。 [0076] Optionally, the front cover having aligned apertures provided for assembly purposes, to ensure accurate alignment of the ultrasonic welding process of the front cover and the intermediate body. 对齐孔周围的升高的凸出部有助于最大化与焊接装置的对齐销的接触以使得塑料不会由于摩擦而容易地熔化。 Raised portion projecting around the aligned apertures helps to maximize the contact with the alignment pin of the welding apparatus so that the plastic does not easily melted by friction. 这些凸出部并不接触中间主体并且不焊接到中间主体以保证孔是特定的(patent)。 These projections are not in contact with the intermediate body and the intermediate body is not welded to the hole to ensure a specific (patent).

[0077] 图3a提供本发明的紧凑歧管的中间主体部件的透视图。 [0077] Figure 3a is a perspective view of the present invention to provide intermediate body member compact manifold. 如图3所示,血液透析/血液过滤系统的整个血液和透析液流动路径301模制到中间主体中。 As shown in FIG. 3, the whole blood and dialysate flow path of a hemodialysis / hemofiltration system 301 molded into the intermediate body. 用于血液提纯系统的各个功能元件302例如泵、阀和传感器的容纳器集成到紧凑歧管的中间主体部分中。 Respective functional elements of the system 302 for blood purification such as pumps, valves and sensors receiving integrated compact to an intermediate body portion of the manifold.

[0078] 中间主体可以由BASF Terlux 2802HD,ABS模制而成。 [0078] The intermediate body may be made of BASF Terlux 2802HD, ABS molded. 另一替代的ABS是Lustran348,White。 ABS is another alternative Lustran348, White. ABS由于其生物相容性以及对超声波焊接的兼容性而被选取。 ABS due to its biocompatibility and compatibility of ultrasonic welding is selected. 中间主体连同前盖提供用于歧管的流体路径通道。 The intermediate body together with the front cover to provide a fluid path for passage of the manifold. 中间主体包含用于对接接头类型的超声波焊接的能量导引器。 The intermediate body comprises an energy director for ultrasonic welding of butt joints of the type. 在一个实施例中,能量导引器的尺度为.019”高、.024”宽的底座。 In one embodiment, energy director for the dimensions .019 "high and .024" wide base. 这产生.00023平方英寸的横截面积。 This produces .00023 square inch of cross-sectional area. 焊接表面的宽度为.075”,从而产生大约.003"x.075”的焊接体积。对接接头类型的能量导引器由于其简单性以及能够控制模制部分的几何尺寸而比其它类型例如剪切接头、舌部和凹槽、阶梯接合,更为优选。通风孔设置在焊接几何结构中以防止俘获的气体强迫地通过焊接处,从而产生会导致泄漏的劣质的焊接。 The width of the welding surface is .075 ", resulting in about .003" x.075 "weld volume. Butt joint energy director type of its simplicity and the ability to control the geometry of the molded part due to the cut than other types e.g. cut joint, tongue and groove, the engagement step, preferably more ventilation holes provided in the weld geometry to prevent gas trapped by forcibly weld, resulting inferior leakage can cause welding.

[0079] 中间主体的后盖侧优选地提供模制在里面的纹理表面以帮助促进后盖和中间主体之间的更好的接合。 [0079] Preferably, the rear side of the intermediate body is provided inside the molded textured surface to help facilitate a better engagement between the cover and the intermediate body. 该纹理表面是本领域技术人员知晓的化学蚀刻工艺。 The textured surface is known to those skilled in the chemical etching process. 优选的纹理深度为.0045”。其它的适当的纹理也可以是激光蚀刻。待焊接在中间主体上的表面设计有.003”的凹陷,其转换为模具上的.003”的升高表面。一旦在模具上产生纹理,该.003”表面的高度降低,因为.0045”纹理深度的峰和谷,所以可假定的是,平均值为该数量的一半,或者.00225”。 Preferred texture depth of .0045 ". Other suitable texture may be a laser etching. Surface to be welded to the intermediate body designed with .003" of the recess, which is converted into the mold .003 "raised surface. Once the texture on the mold, the .003 "height of the surface is reduced, since .0045" depth of the texture of peaks and valleys, it can be assumed that, for the half of the average, or .00225. " 该结果使得模具处于.00075”的钢安全条件中。 The result is that the mold .00075 "steel safe conditions.

[0080] 待焊接的模具的尺度会对超声波焊接工艺的成功具有主要影响。 [0080] Successful scale ultrasonic welding process will be welded mold having a major influence. 表面积越大,焊接工艺越困难。 The larger the surface area, the welding process more difficult. 重要的是,精确控制焊接表面。 Importantly, the precise control of the welding surface. 在前盖和后盖中的均一厚度比平面度更为重要,因为在焊接工艺过程中,平面度稍微偏离的盖子将被挤压为平的。 Front and rear covers of uniform thickness is more important than flatness, because the welding process, the flatness of the lid will be offset slightly pressed flat. 在中间主体上的平面度由于防止它在焊接工艺过程中变平的结构设计而是重要的。 Flatness on the intermediate body due to the structural design to prevent that during the welding process is important, but flattened. 由于这些问题,非常重要的是,这些部分正确地设计并且不会趋于变形,例如翘曲、下沉,尺寸变化等。 Because of these problems, it is important that these parts are not properly designed and tend to deform, such as warpage, sink, size changes. 此外,模具结构和质量需要达到所述部分需要满足的高标准。 Furthermore, the mold structure and the need to meet high standards of quality of the portion to be met. 相应地,模制工艺控制也将要求最高的标准。 Accordingly, the molding process also requires the highest control standards.

[0081] 后盖可以由BASF Terlux 2802HD,ABS模制。 [0081] The cover may be formed from BASF Terlux 2802HD, ABS molding. 后盖包含用于对接接头类型的超声波焊接的能量导引器。 Cover comprising energy director for ultrasonic welding of butt joints of the type. 能量导引器的尺度是.019”高、.024”宽的底座。 Scale energy director is .019 "high and .024" wide base. 这导致.00023平方英寸的横截面积。 This leads .00023 square inch of cross-sectional area. 焊接表面的宽度是.075”,从而产生大约.003” X.075”的焊接体积。该.003”焊接体积在当确定组装的部件的几何结构是应当考虑。 The width of the welding surface is .075 ", resulting in about .003" X.075 "weld volume. The .003" weld volume when determining the geometry of the assembled components that should be considered. 通风孔设置在焊接几何结构中以防止俘获的气体强迫地通过焊接处,从而产生会导致泄漏的劣质的焊接。 Vent hole is provided in the weld geometry to prevent the trapped gas through the weld forcedly, resulting inferior leakage can cause welding. 在后盖中的对齐孔被提供用于组装目的以保证在超声波焊接工艺过程中后盖精确对齐中间主体。 Aligned holes in the back cover are provided for assembly purposes to ensure that an ultrasonic welding process accurately aligned with the rear intermediate body. 在后盖中的对齐孔还提供在正确装载时歧管和仪器的精确对齐。 Aligned holes in the back cover also provides precise alignment of the manifold and the instrument when properly loaded. 对齐孔周围的升高的凸出部设计来最大化与焊接夹具的对齐销的接触,以使得塑料不会由于摩擦而轻易地熔化。 Raised portion projecting around the aligned holes designed to maximize contact with the alignment pin of the welding jig, so that the plastic does not easily melted by friction. 这些凸出部并不接触并且不焊接以保证孔是特定的。 These projections are not in contact and to ensure that the holes are not welded specific.

[0082] 超声波焊接由于其制造工艺的低成本而作为用于接合歧管三个主要部件的方法而被选取。 [0082] The ultrasonic welding because of its low cost manufacturing process is selected as a method for three major components of the manifold engagement. 产生焊接属性的相对低的设备成本和周期时间导致这种更低的制造成本。 Weld properties and relatively low cost equipment such cycle times result in lower manufacturing costs. 一旦各个部分装载到固定设备中,具有操纵杆的移动和移除的焊接周期可以在几秒内完成。 Once loaded into the various parts of the fixation device having a lever movement and removal of the welding cycle can be completed within a few seconds. 实际的焊接时间为大约一秒。 Actual welding time is about one second. 其它接合方法包括热板、激光器和UV胶粘剂。 Other bonding methods include hot plate, laser, and UV adhesives.

[0083] 参照图3a,在一个实施例中,中间主体部分300在其中集成有三个双路阀307、五个压力传感器306、一个梗塞检测器、一个气泡检测器和一个血液泄漏检测器。 [0083] Referring to Figure 3a, in one embodiment, the intermediate body portion 300 in which the integrated three-way valve 307, five pressure sensor 306, a detector infarct, a bubble detector and a blood leak detector. 本领域技术人员将认识到,集成到中间主体部分300中的功能部件的数量和类型可以根据血液提纯系统的要求和应用而改变,因此可以包括1、2、3、4、6、7、8、9、10或者更多压力传感器,1、2、4、5、6或者更多的双路阀,0、2、3、4或者更多的梗塞检测器,0、2、3、4或者更多的气泡检测器,0、2、3、4或者更多血液泄漏检测器。 Those skilled in the art will recognize that the number and type of integrated functions of the body member of the intermediate portion 300 may vary depending on the application requirements and the blood purification system, may therefore include 1,2,3,4,6,7,8 , pressure sensors 9, 10 or more, or more two-way valve 1,2,4,5,6, 0,2,3,4 or more detectors infarction, or 0,2,3,4 more bubble detector, 0,2,3,4 or more blood leak detector. 此外,中间主体部分300包括多个端口303、304。 Further, the intermediate body portion 300 includes a plurality of ports 303, 304.

[0084] 端口包括内部端口304,流体经由泵部分(未示出)从歧管300的第一和第二部分和在第一和第二部分之间流动通过内部端口304。 [0084] The port comprises an internal port 304, fluid (not shown) from the manifold portion and the first and second ports through the internal flow between the first and second portions 300, 304 via a pump portion. 在一个实施例中,第一部分具有四个内部端口304,在第一部分和连接部分连接的点的每个侧面上分别两个端口。 In one embodiment, first portion 304 has four internal ports, two ports are on each side of the first portion and the connection point of the connecting portion. 应当认识到,第一部分可以具有1、2、3、5、6、7或者更多的内部端口。 It should be appreciated that the first portion may have 1,2,3,5,6,7 or more internal ports. 在一个实施例中,第二部分具有四个内部端口304,在第一部分和连接部分连接的点的每个侧面上分别两个。 In one embodiment, second portion 304 has four internal ports, two on each side of each point of the first connecting portion and the connecting portion. 应当认识到,第二部分可以具有1、2、3、5、6、7或者更多的内部端口。 It should be appreciated that the second portion may have 1,2,3,5,6,7 or more internal ports. 此外,优选地,第一部分的内部端口的位置和定位与第二部分的内部端口的位置和定位镜像对称。 Further, preferably the location and position, the location and position of the internal ports of the first portion and the second portion of the interior of the port mirror symmetry. 端口还包括到歧管300外部的元件的外部端口303。 Further comprising a manifold port 300 to the outside of the tube member 303 of the external ports. 在一个实施例中,第一部分具有两个外部端口303。 In one embodiment, first portion 303 has two external ports. 在一个实施例中,第二部分具有十个外部端口304。 In one embodiment, the second portion having an external port 304 ten. 在一个实施例中,第一部分具有1、3、4、5、6、7、8、9、10、11、12、13、14、15或者更多的外部端口303。 In one embodiment, the first portion having 1,3,4,5,6,7,8,9,10,11,12,13,14,15 or more external ports 303. 在一个实施例中,第二部分具有1、2、3、4、5、6、7、8、9、11、12、13、14、15或者更多的外部端口304。 In one embodiment, the second portion having 1,2,3,4,5,6,7,8,9,11,12,13,14,15 or more external ports 304.

[0085] 结合流体接触元件到歧管中,如上所述,使得能够设计这样系统:其中可再用的传感器安装在歧管配合到其上的透析设备中,而必要的一次性流体接触元件分离开并布置在歧管中,如上所述。 [0085] The binding element into contact with the fluid manifold, as described above, so that the system can be designed so that: a reusable sensor which is mounted in the manifold to a dialysis apparatus fitted thereon, whereas the contact element necessary disposable fluid separation apart and disposed within the manifold, as described above. 为了保证正确的读数和测量,流体接触元件和可再用的传感器需要对齐。 To ensure correct measurements and readings, the fluid contacting elements and reusable sensors need to be aligned. 歧管和透析设备之间的配合和对齐关于定位和施加压力是关键的。 Fit between the manifold and the dialysis apparatus and aligned on the positioning and application of pressure is critical. 典型地,这样的配合精度必须提供在X、Y和Z方向.001”-.010”的容差并施加在10-100PSI的安装力以通过歧管抵抗流体力。 Typically, such accuracy must be provided with X, Y and Z directions .001 - tolerance. "010" and the fluid force exerted against the manifold in the installation through the force 10-100PSI. 这样的关键的定位通过在歧管上的特定设计的定位表面实现,所述定位表面与透析设备上的互补定位表面对准。 This critical positioning surface is positioned on the manifold by a particular design implementation, the complementary positioning surface and the positioning surface of align the dialysis device. 要求的力通过透析设备结构的分析和设计而被递送以允许在操作过程中在歧管内形成的全部流体和机械压力下X和Y位置和Z方向偏转小于大约.001”-.010”。 The force required by the analysis and design configuration of the dialysis machine and delivered to allow the X and Y position and Z directions under mechanical pressure and all of the fluid within the manifold is formed during operation of deflection of less than about .001 "-. 010". 因为歧管包含在一个整块的基板上的许多结构,这样的关键对齐仅需要一旦用于定位歧管的全部的特征以及透析设备的全部的配合特征时完成。 Because the manifold comprising a plurality of structures on a substrate in a monolithic, this alignment only when all of the key features of all of the mating features and dialysis equipment needed to complete the positioning of the manifold once used.

[0086] 参照图9,在一个实施例中,歧管902安装在透析系统901的竖直前面板903上。 [0086] Referring to FIG 9, in one embodiment, the manifold 902 is mounted on a vertical front plate 903 of the dialysis system 901. 歧管通过多个对齐机构准确定位在该面板903上。 The manifold 903 is positioned on the panel by a plurality of precise alignment mechanism. 第一对齐机构包括多个在面板903中的对齐销,其接合歧管902中的对齐孔。 First alignment means comprises a plurality of alignment pins in the panel 903, which engages the aligned holes 902 in the manifold. 第二对齐机构包括至少一个锁闩,其保持歧管903在特定的安装位置,直到门906闭合并且最终的精确位置得以获得。 Second alignment means includes at least one latch, which holds the manifold 903 at a specific mounting position, until the door 906 is closed and the final position is accurately obtained. 在一个实施例中,歧管的后盖在顶部和底部具有两个设计在其中的凸片。 In one embodiment, the back cover has two manifold design in which the tabs at the top and bottom. 这些凸片在门闭合以及随后布置歧管的精确位置之前锁闩歧管在第一保持位置。 The exact position of the tabs before the door is closed and subsequently the manifold latch arrangement manifold holding a first position. 凸片使得锁扣机构能够手动释放或者通过球体制动器释放,所述球体制动器要求用手强迫地移除歧管。 Tab so that the latch mechanism can be released manually or by releasing the brake ball, said ball and brakes manifold forcibly removed by hand. 在另一个实施例中,锁闩机构包括在后盖顶部上的弹簧加载的插入和释放机构。 Embodiment, the latch mechanism and release mechanism includes an insert on top of the back cover in another embodiment of a spring-loaded. 该机构具有在顶部锁闩和底部锁闩之间的连杆。 The link mechanism having a latch between the top and bottom of the latch. 当在顶部的释放机构被促动时,底部锁闩也释放。 When the release mechanism is actuated at the top, bottom, also releases the latch.

[0087] 第三对齐机构包括外形导引器908,其导向歧管902的整体位置和构型。 [0087] The third alignment mechanism includes a guide profile 908, which guide the overall position of the manifold 902 and configuration. 外形导引器908优选地成形为与歧管902的物理结构配合、匹配或者否则互补。 Guide profile 908 is preferably shaped to the physical structure of the manifold 902 and mating, complementary to match or otherwise. 在一个实施例中,导引器908总体为矩形并配置来配合在由第一部分、第二部分和连接部分的侧面界定的空间内部。 In one embodiment, the guide 908 is generally rectangular and configured to fit the interior space by a first portion, a second portion and the connecting portion of the side defined. 第四对齐机构包括门906,其具有至少一个弹簧装载压力板905,该板905将歧管902保持在门906和前面板903之间,从而施加用于阀和压力传感的足够压力。 A fourth alignment mechanism includes a door 906, which has at least one spring loaded pressure plate 905, the plate 905 remains in the manifold 902 between the door 906 and the front panel 903, so that sufficient pressure is applied to the valve and pressure sensing. 门906还包括四个压力靴,其施加足够压力到泵送部件用于流体的旋转蠕动递送。 Gate 906 also comprises four pressure shoe which sufficient pressure is applied to the rotary peristaltic pump for fluid delivery member. 应当认识到,可以使用单独或者组合一个或多个对齐机构,以实现必要的对齐和用于歧管的受压位置。 It should be appreciated, may be used alone or in combination with one or more alignment mechanisms to achieve the necessary alignment and a depressed position of the manifold. 应当进一步认识到,对齐机构附连到透析装置壳体内的凹陷区域的表面。 It should further be appreciated that the alignment mechanism is attached to the surface of the recessed area in the dialysis device housing. 凹陷区域包括前面板903,面板903相对于透析装置壳体凹陷并由四个壁(第一壁、第二壁、第三和第四壁)界定,所述四个壁从前面板903向上延伸以接触并固定地附着到透析装置壳体。 Recessed region includes a front panel 903, the panel 903 with respect to the housing by means of four walls dialysis recess (first wall, second wall, third and fourth wall) define the four walls extending upwardly from the front panel 903 to contacting and fixedly attached to the dialysis apparatus housing. 凹陷足够深并配置来接收门906。 Recesses deep enough and configured to receive the gate 906.

[0088] 中间主体通道尺寸在中间主体侧面上的通道的底部边角处名义上为在.190”深、.190”宽、.020”半径的范围内。在通道的底部边角处的半径应当是最大的以防止在通道壁下方产生沉孔。这些通道壁具有在中间主体的相对侧面上的阀和压力膜片几何结构,其在这些区域会不利地受到沉孔的影响。在一个实施例中,流体通路是正方形的。防止沉孔的总的设计规则是肋部(在这种情况中通道壁)的壁厚度应当不超过它所附着到的相邻壁的50-60%。通道壁是.075”,相邻的壁(主歧管结构)是.130”,从而产生58%。.190,,χ.190”的透析液通道通过孔过渡到.155”管子端口。这最小化对齐前盖与中间主体所需的精度并最小化更厚的壁产生沉孔的可能性,所述沉孔会影响在中间主体的相对侧面上的密封特征。相同的方法可以用于抗凝血剂和注入液通道。稍微的弯曲设计 [0088] The bottom corners of the nominal channel dimensions intermediate body passage on the side of the intermediate body as .190 "deep and .190" wide, the range of .020 "radius of the radius at the bottom corners of the channel it is the biggest hole in the sink to prevent the lower channel wall. the channel walls has a valve geometry and a pressure diaphragm on opposite sides of an intermediate body, which adversely affected the counterbore in these regions. in one embodiment embodiment, the fluid passage is square. counterbore to prevent design rule is the total rib (in this case the channel walls) should not exceed 50-60% of the wall thickness of it is attached to the adjacent walls. passageway wall is .075 "adjacent walls (main manifold structure) is .130" to produce a 58% .. 190,, χ.190 "dialysate passage through the aperture transition to .155" tube port. this minimizes intermediate body cover required accuracy of alignment of the front and minimize thicker walls produced counterbore possibility, sealing features may affect the counterbore on opposite sides of the intermediate body. the same method can be used anticoagulation blood and infusate agent channel. slightly curved design 通道中以最大化层流并最小化紊流。在一个实施例中,抗凝血剂和注入液通道,如下面讨论的,测量为.190”深、.100” 宽。 Channel to maximize laminar flow and minimize turbulence. In one embodiment, the anticoagulant fluid injection channel and, as discussed below, measured as .190 "deep and .100" wide.

[0089] 在一个实施例中,中间主体具有用于组装目的的对齐孔以保证前盖和后盖在超声波焊接工艺过程中与中间主体精确对齐。 [0089] In one embodiment, the intermediate body having aligned apertures for assembly purposes to ensure that the front and back covers precisely aligned with the intermediate body in an ultrasonic welding process. 在对齐孔周围的升高的凸出部最大化与焊接夹具的对齐销的接触以使得塑料不会由于摩擦而轻易地熔化。 The contact pins are aligned with the projections to maximize the welding fixture is aligned around the hole so that the plastic does not rise due to friction and easily melted. 这些凸出部并不接触并且不焊接以保证孔是特定的。 These projections are not in contact and to ensure that the holes are not welded specific.

[0090] 图4是示出根据本发明的一个实施例的用于紧凑歧管的流体回路的细节的图形。 [0090] FIG. 4 is a diagram showing details of a fluid circuit for a compact manifold according to one embodiment of the present invention. 流体回路包括四个蠕动泵Ρ1401、Ρ2402、Ρ3403和Ρ4404。 Fluid circuit includes four peristaltic pumps Ρ1401, Ρ2402, Ρ3403 and Ρ4404. 它进一步包括五个压力传感器S1405、S2406、S3407、S4408和S5409,和一个温度传感器S6410。 It further comprises a pressure sensor five S1405, S2406, S3407, S4408 and S5409, a temperature sensor, and S6410. 在如图4所示的实施例中,三对阀-VlA和V1B411、V2A和V2B 412和V3A和V3B 413-集成到歧管中。 In the embodiment illustrated in Figure 4, three pairs of valves and -VlA V1B411, V2A and V2B 412 and V3A and V3B 413- integrated into the manifold. 以这种方式归类,六对单向阀411Α、Β,412Α、Β,413Α、Β形成三个双路阀组件411、412、413。 In this way classification, six pairs of one-way valve 411Α, Β, 412Α, Β, 413Α, Β three-way valve assembly 411, is formed.

[0091] 泵管部分401、402、403、404接合到紧凑歧管中。 The engagement portion 401 402 403 404 [0091] tubing into a compact manifold. 多个端口设置在歧管中,其与歧管外部的管连接以允许各流体流入和流出歧管。 A plurality of connection ports provided in the tube manifold, which manifold to allow each of the external fluid into and out the manifold. 这些端口连接到血液提纯系统中的各个管,用于传送流体,如下: These ports are connected to the blood purification system in each tube for conveying fluid, as follows:

[0092] 端口Α415-血管到透析器430 ; [0092] Vascular Α415- port 430 to the dialyzer;

[0093] 端口B 416-透析器输出(用过的透析液); [0093] B 416- dialyzer output port (spent dialysate);

[0094] 端口C 417-来自患者的血液; [0094] Port C 417- blood from a patient;

[0095] 端口D 418-用于混合在血液中的肝素; [0095] D 418- ports for mixing the heparin in the blood;

[0096] 端口E 419-储存器输出(新的透析液); [0096] E 419- reservoir output port (new dialysate);

[0097] 端口F 420-透析器输入(新的透析液); [0097] input port of the dialyzer F 420- (new dialysate);

[0098] 端口G 421-透析器输出(血液); [0098] G 421- dialyzer output port (blood);

[0099] 端口H 422-患者返回(清洁的血液); [0099] Patients return port H 422- (cleaner blood);

[0100] 端口J 423-连接到充灌和排出线路; [0100] J 423- port connected to the filling and discharge line;

[0101] 端口K 424-储存器注入液输入; [0101] K 424- port input infusate reservoir;

[0102] 端口M 425-来自注入液储存器的注入液; [0102] M 425- port infusate from the infusate reservoir;

[0103] 端口N 426-透析液流入吸附剂。 [0103] N 426- port dialysate flowing into the adsorbent.

[0104] 在一个实施例中,形成为模制到歧管结构400中的通路的管部分连接肝素的流体流动,经由端口D418进入到血液的流体流动,经由端口C 417进入。 [0104] In one embodiment, a fluid flow passage is molded into the configuration of the manifold 400 is connected heparin tube portion, the flow of blood into the fluid via port D418, enters via port C 417. 组合的肝素和血液流动通过端口417a,经由泵401,并进入歧管400的端口417b。 The combination of heparin and blood flow through the port 417a, via a pump 401, and into the manifold port 417b 400. 压力传感器与形成为模制在歧管结构400中的通路的管部分物理连通,该管部分相应地使得血液和肝素流体通过端口A415。 The pressure sensor is formed in the mold manifold structure 400 of the physical communication path tube portion, the tube portion respectively such that the blood fluid through the port and heparin A415. 在端口A415从歧管400流出的流体通过位于歧管400外部的透析器430。 A415 port fluid flowing from the manifold tube 400 through manifold 400 positioned outside of the dialyzer 430. 透析的血液通过端口G 421向后通入歧管400中,并进入管部分中,该管部分形成为模制到歧管结构400中的通路,也就是与压力传感器407物理连通。 The dialyzed blood through port G 421 back into manifold 400, and into the tube portion, the tube portion is formed as a molded passage to manifold structure 400, which is in communication with the pressure sensor 407 physically. 流体然后从管部分通过端口H 422并进入患者返回线路。 Then the fluid from the pipe portion H 422 through the port and into the patient return line.

[0105] 单独地,透析流体从储存器经由端口E 419进入歧管400。 [0105] Separately, the dialysis fluid from the reservoir into the manifold 400 via port E 419. 在储存器中的流体具有在其中的注入液,流体经由端口M 425进入歧管400,通过形成为模制在歧管结构400中的通路的管部分,通过另一个端口425a,通过泵402,经由端口425b回到歧管400中。 Infusate fluid reservoir having therein a fluid port 425 into the manifold M via pipe 400, is formed by the molded part passage in the manifold structure 400, through another port 425a, through the pump 402, Back 425b via port manifold 400. 注入液通过形成为模制在歧管结构400中的通路的管部分,并在端口K 424从歧管400出来,在那里它通入储存器中。 By forming the liquid injection molded part passage in the manifold structure 400, K 424 and the port 400 out of the manifold, where it is introduced into the reservoir. 经由端口E 419进入的透析流体通过形成为模制在歧管结构400中的通路的管部分,通过另一端口419a,通过泵403,并经由端口419b返回到歧管400中。 E 419 via the dialysis fluid entering through port is formed in the molded portion of the passage in the manifold structure 400, through another port 419a, through a pump 403, and returns into the manifold 400 via port 419b.

[0106] 透析液流体通入形成为模制到歧管结构400中的通路的管部分,该管部分与一对阀411物理连接。 [0106] dialysate fluid is formed into a molded tube portion 400 to passage manifold structure, the tube part is connected to a pair of valves 411 physically. 形成为模制到歧管结构400中的通路的管部分使得透析液流体通过到达另一对阀413。 It is formed so that the dialysate fluid is molded into the passage 400 of the manifold structure to the other through the tube portion 413 of the valve. 管部分与压力传感器408以及任选的温度传感器410物理连通。 Tube portion 410 and the pressure sensor 408, and physical communication optional temperature sensor. 透析液流体通过端口F 420从歧管400出来,进入通入到透析器430中的线路中。 Dialysate fluid through port F 420 from the manifold 400 out, enters into the dialyzer 430 lines.

[0107] 从透析器430出来的线路使得流体通过端口B 416回通到歧管400中,并进入管部分中,该管部分形成为模制到歧管结构400中的通路,也就是与第一对阀411、第二对阀412和压力传感器406物理连通。 [0107] From the dialyzer 430 out of the line such that the fluid passage through the port B 416 back into the manifold 400, and into the tube portion, the tube portion is formed as a molded into the passage 400 of manifold structure, i.e. the first a pair of valves 411, second valve 412 and a pressure sensor 406 communicates physically. 使用过的透析液流体通过端口426B从歧管400出来,通过泵404,经由端口426a回到歧管中。 Used dialysate fluid out through the port 426B from the manifold 400 by a pump 404 via port 426a back manifold. 与端口426a流体连通的管部分与压力传感器409物理连通并使得流体通过端口N 426并到吸附剂再生系统。 Pipe portion 426a and the pressure sensor port 409 in fluid communication through the physical communication port and allow fluid to the sorbent and N 426 regeneration system.

[0108] 管子端口设计用于回路管子.268”x.175”管子或者抗凝血剂和注入液管子.161”X.135”。 [0108] Port tubes designed for circuit tubing .268 "x.175" or anticoagulant tube and the liquid injection pipe .161 "X.135". 优选地,管子端口与适当的溶剂接合。 Preferably, the tube engaging port with a suitable solvent.

[0109] 在一个实施例中,双路阀通过使得安装在仪器上的阀致动器压缩火山密封上的弹性膜片以防止透析液流动通过它的各通路而进行操作。 [0109] In one embodiment, the two-way valve through a valve mounted on the instrument so that the actuator compress the elastic diaphragm seal to prevent volcanic dialysate flow operate by each of its passages. 火山密封开口为大约.190”直径以匹配通道几何结构。通过阀内部的横截面通路至少等效于阀打开时.190”直径。 Volcanic sealing the opening is about .190 "diameter to match the geometry of the channel through the interior of the valve passage cross section at least equivalent to the valve opens .190" diameter. 当阀处于闭合位置时,阀致动器和弹性膜片消耗火山密封周围的大部分流体路径空间,从而最小化进入空气的可能性。 When the valve is in the closed position, the valve actuator and consume most of the fluid path elastic diaphragm sealing the space surrounding the volcano, so as to minimize the possibility of incoming air. 在中间主体上具有升高的塑料特征,其最小化流体路径内的死空间,以及放逐防止膜片在负压力情形下在中心流体路径周围坍塌。 Plastic having raised features on the intermediate body, the dead space within which minimizes the fluid path, and prevents the diaphragm from collapsing exiled fluid path around the center under negative pressure situations. 弹性膜片具有围绕它的周边的O圈特征,该O圈配合到中间主体表面上的凹槽中。 Wherein the elastic diaphragm has O ring around its periphery, the O-ring fitted into a groove on the surface of the intermediate body. O圈挤压在中间主体和后盖之间以形成流体紧密封。 O-ring pressed to form a fluid tight seal between the intermediate body and the back cover. 提供该设计,用于在O圈上大约30%的压缩。 This design provides for compressing the O-ring in about 30%. 双路阀控制透析液流动通过歧管的方向。 Two-way valve controls the direction of dialysate flow through the manifold.

[0110] 中间主体包含允许通过利用仪器中的传感器跨过膜片监测流体压力的结构。 [0110] intermediate body comprising monitoring the fluid pressure allowed across the membrane by using the instrument sensor structure. 流体被允许通过在后盖侧面上的膜片下面的入口和出口孔从中间主体的前盖侧面上的通道流动。 Fluid is allowed to pass through the membrane on the back cover side of the inlet and outlet orifices below the flow passage from the front cover on the side of the intermediate body. 通过压力传感结构的内部的截面通路至少等于.190”。内部通路设计来最小化空气滞留,同时提供与膜片的足够的流体接触。弹性膜片具有围绕它的周边的O圈特征,该O圈特征配合到中间主体表面上的凹槽中。O圈挤压在中间主体和后盖之间以形成流体紧密封。提供该设计,用于在O圈上30%的压缩。 Section through the internal passage of the pressure sensing structure at least equal to .190. "Interior passageway designed to minimize air entrapment, while providing sufficient fluid contact with the diaphragm. Diaphragm having a resilient O ring feature around its periphery, the wherein O-ring fitted into the recess on the intermediate ring .O body surface pressing between the intermediate body and the rear cover to form a fluid tight seal. this design provides for compression of the O-ring 30 percent.

[0111] 阀和膜片可以由各种不同的材料并通过不同工艺进行制造。 [0111] valves and the diaphragm may be manufactured and the various materials by different processes. 在一个实施例中,弹性部件是由硅树脂制造。 In one embodiment, the elastic member is made of silicone. 在另一个实施例中,弹性部件是由各种热塑性塑料弹性体制成。 Embodiment, the elastic member is made of a thermoplastic elastomer in a variety of another embodiment. 两射击模制可以用于附着阀和膜片到后盖。 Two shot molding can be used for attachment to the back cover and the diaphragm valve. 阀和膜片的两射击模制将消除单独组装这些部件到歧管中的需要,因此减小劳动成本并提高歧管组件的质量。 Diaphragm valves and two shot molding would eliminate the need to separately assemble these components in the manifold, thus reducing labor costs and improving the quality of the manifold assembly.

[0112] 泵送部件在歧管设计中已经被限定为PVC头部管。 [0112] In the manifold design pumping member has a head is defined as PVC pipe. 与仪器的旋转蠕动泵送系统组合的这些头部提供血液、透析液和注入液的流动。 The rotary head assembly with the instrument to provide a peristaltic pumping system of the blood, dialysate, and the flow of infusate. 用于透析液、注入液和抗凝血剂的回路管子材料优选为抗扭结的,例如称作Colorite,Unichem PTN 780的管子(80A硬度计),其由Natvar挤压成型,全部是TEKlNlplex公司的。 For dialysate, and anticoagulant fluid injection loop tubing is kink-resistant material is preferably, e.g. called Colorite, Unichem PTN 780 tubes (8OA hardness), which is extruded from the Natvar, all companies TEKlNlplex . 用于透析液线路的管子尺度为从.268,,χ.189” 到.268” X.175” 的范围。 For pipe dimensions from the dialysate line .268,, χ.189 "to .268" X.175 "range.

[0113] 如上面提及的,用于透析系统的紧凑歧管还包括温度传感器(图4中的附图标记410) ο在PAK的一个实施例中,温度传感器位于储存器组件中。 [0113] As mentioned above, the compact manifold for dialysis system further comprises a temperature sensor (reference numeral 4 in FIG. 410) ο PAK In one embodiment, the temperature sensor is located in the reservoir assembly. 但是,温度传感器还可位于储存器组件外面,并且在这样的实施例中,它可以集成到歧管中,如图4所示。 However, the temperature sensor may also be located outside of the reservoir assembly, and in such an embodiment, it may be integrated into the manifold, as shown in FIG.

[0114] 将温度传感器集成到歧管中有三个主要的方法。 [0114] The temperature sensor is integrated into three main methods manifold. 本领域技术人员将认识到,可以对每一方法进行变化,而不引起歧管总体设计的任何明显变化。 Those skilled in the art will recognize that changes may be made for each method, without causing any significant change in the overall design of the manifold. 这些方法讨论如下: These methods are discussed below:

[0115] 高传导性流体接触: [0115] a high conductivity fluid contact:

[0116] 在高传导性直接流体接触方法中,金属盘构建到歧管的壁中,本领域已知的热敏电阻或者任何其它的适当的温度传感器布置为与透析设备侧面上的盘接触,与患者侧面上的流体接触。 [0116] In a high conductivity direct contact with the fluid process, the metal plate is built into the wall of the manifold, a thermistor known in the art, or any other suitable temperature sensor disposed in contact with the side surface of the disk on the dialysis device, contacting the fluid with the sides of the patient. 流体温度因此可以通过金属盘进行监测。 Thus the temperature of the fluid can be monitored by a metal plate.

[0117] 传统地,温度通过直接布置热敏电阻在流体流中而进行监测。 [0117] Conventionally, the temperature in the fluid flow monitored by a thermistor arranged directly. 使用金属盘来监测本发明中的温度提供避免污染以及因此清洁热敏电阻的需要的优点。 The advantage of using a metal plate to monitor the temperature in the present invention provided it is necessary to avoid contamination and cleaning of the thermistor.

[0118] 本领域技术人员将认识到,任何适当金属例如316类型的不锈钢的金属盘可以用于该目的。 [0118] Those skilled in the art will recognize that any suitable metal such as stainless steel type 316 metal disk can be used for this purpose. 进一步地,可以采用对于当前应用适当的任何的热敏电阻。 Further, the current application may be employed for any appropriate thermistor. 示例性热敏电阻是由Beta Therm制造的零件号码1K 3A1A。 Exemplary thermistor is manufactured by Beta Therm part numbers of 1K 3A1A.

[0119] 在一个实施例中,金属盘是用于单个患者使用的,并且为一次性的,并且热敏电阻是透析设备的一部分并且可以再次使用。 [0119] In one embodiment, the metal disk is a single patient use and disposable, and the thermistor is part of the dialysis device and can be used again.

[0120] 介质传导性流体接触: [0120] Media conductive fluid contact:

[0121] 紧凑歧管的压力传感器膜(图2的附图标记202)是相对薄的,并且由介质导热性材料构成。 [0121] compact manifold pressure sensor diaphragm (reference numeral 202 in FIG. 2) is relatively thin and is made of thermally conductive dielectric material. 典型的.040”的厚度被使用,并且能够在.005” 050”中变化。材料越薄并且导热性越高,压力传感器膜将越高精度地传递透析流体的温度到安装在透析设备内部的压力传感器。通过设计,它们与在设备侧面上的压力传感器和患者侧面上的流体直接接触。布置适当温度的传感器在压力传感器内部允许监测流体温度。本领域已经知晓的某些压力传感器包括用于修正由于温度漂移所致的传感器的温度传感器。这样的具有温度传感特征的压力传感器可以用于本申请的目的。示例性的组合的压力-温度传感器是由MicronInstruments制造的型号MPT40。采用这样的传感器的组合避免测量的流体的直接接触并减小歧管中部件的数量。这提供对如在前面的方法中使用的金属盘的替代。 Typical .040 "thickness is used, and is capable of .005" 050 change. "Thinner material and the higher the thermal conductivity, pressure sensor diaphragm will be more accurately transmitted to the mounting of the dialysis fluid temperature in the interior of the dialysis device the pressure sensor. by design, they are in direct contact with the fluid on the pressure sensor and the patient on the side surface side of the device. the sensor is disposed within a suitable temperature to allow the pressure sensor monitoring the fluid temperature. some pressure sensors already known in the art including for the correction due to temperature drift caused by a temperature sensor such as the sensor a pressure sensor having a temperature sensing characteristic may be used in the present application, an exemplary object combined pressure - temperature sensor is a type of MPT40 manufactured by such a MicronInstruments. combination of sensors to avoid direct contact of the fluid to be measured and reducing the number of manifold components. this provides an alternative to the metal disk as used in the previous method.

[0122] 间接光学温度测軍: [0122] Indirect measurement optical temperature Jun:

[0123] 如果歧管流体路径的塑料壁是有限厚度的,例如大约.020”,那么塑料壁将使得歧管内部的流体的温度平衡。在这样的情形下,非接触的光学温度测量可以从薄壁的外面进行,并且可以确定内部的流体温度。示例性的非接触光学温度传感器是由Melxis制造的零件号码MLX90614。非接触的方法提供优点:它不需要在歧管中的额外的部件。唯一的要求是在流体路径壁中的薄的部分。该方法提供低成本并且仍保持单一患者使用安全特征。 [0123] If the plastic wall of the manifold fluid path is of finite thickness, for example, about .020 ", then the temperature of the plastic walls that will balance the fluid inside the manifold. The optical temperature measurement in such a case, from the non-contact We were outside the thin-walled, and may determine the temperature of the fluid inside an exemplary temperature sensor is a non-contact optical methods of part number MLX90614 manufactured by Melxis noncontact provide advantages: it requires no additional components in the manifold. the only requirement is that the thin portion of the wall in the fluid path. the method provides a low cost and still maintain a single patient use security features.

[0124] 除了压力传感器和温度传感器,其它的传感器也可以被包括进来,用于与紧凑歧管集成。 [0124] In addition to pressure and temperature sensors, other sensors may also be included, for integration with a compact manifold. 这些其它的传感器包括,但是不限于,氨传感器、pH传感器和电导率传感器。 Such other sensors include, but are not limited to, ammonia sensors, pH sensors and conductivity sensors. 氨和PH传感器可以作为单个采取集成到歧管中,或者作为包括两个传感器的单一“模块”。 Ammonia and PH sensors may be taken as a single integrated into the manifold, or as a single "module" includes two sensors.

[0125] 在歧管中的一体的电导传感器的一个可能的实施例是作为具有接触透析液流体的电销的电导率单元。 [0125] conductivity sensor integrated in the manifold of a possible embodiment as a dialysate conductivity cell has a contact pin of an electrical fluid. 示例性的电导率单元的技术细节示出在图5中。 Exemplary technical details of the conductivity cell shown in FIG. 5. 参照图5,电导率单元500包括用于施加小的稳定的电流到流体的偏压销501。 Referring to FIG. 5, for stabilizing the conductivity unit 500 includes a small current is applied to bias pin 501 fluid. 传感销502检测流体中的电压,其中检测到的电压的大小依赖于流体的电导率和温度。 Voltage sense pin 502 detects fluid, wherein the size of the detected voltage depends on the conductivity and temperature of the fluid. 通过利用挨着电导率单元500布置的热敏电阻503测量温度。 By using the next cell conductivity thermistor 503 measures the temperature of 500 is disposed. 替代地,温度可以由上面公开的方式之一进行确定。 Alternatively, the temperature can be determined by one of the above-disclosed embodiment. 在已知在传感销502处测量的温度和电压的值的情况下,流体的电导率可以被确定。 In the case of known value measured in the sensing pin 502 and the voltage of the temperature, conductivity of the fluid may be determined.

[0126] 通过偏压销501施加的电流可以是直流或者交流信号,并且一般是在50-100千赫频率范围。 [0126] current applied by the biasing pin 501 may be a DC or an AC signal, and is generally in the 50-100 kHz frequency range. 在一个实施例中,施加的电流的大小是在1mA数量级的。 In one embodiment, the magnitude of the current applied in the order of 1mA. 传感销502 —般在电导率单元的制造过程中定位的深度的,典型地对于单元中的cal溶液为到±0.001英寸的深度。 Sensing pin 502-- as positioned during manufacture of the electrical conductivity in the depth of the unit, typically for a unit of cal solution to a depth of ± 0.001 inches. 热敏电阻503具有0.5摄氏度的典型精度。 The thermistor 503 has a typical accuracy of 0.5 degrees Celsius.

[0127] 电导率单元可以通过驱动或者模制就位传导销(偏压销和传感销)到歧管主体中以使得它们接触透析液但是不允许透析液泄漏到歧管外面而构建到紧凑歧管的透析液流体通路中。 [0127] Conductivity or drive unit may be molded in place by conductive pin (pin and biases sensing pin) to the manifold so that they contact the body but does not allow the dialysate dialysis fluid leaking to the outside manifold built into a compact dialysate fluid passage of the manifold.

[0128] 在一个实施例中,用于血液泄露、气泡和/或梗塞的传感通过在透析设备中包括光学传感器而实现,所述透析设备附着到并围绕歧管的预定区域。 [0128] In one embodiment, for blood leaks, bubbles and / or infarction sensor comprises an optical sensor is achieved by the dialysis device, the dialysis device is attached to and surrounding a predetermined region of the manifold. 回过来参照图3a,歧管300包括多个管子支撑支架322,其有利于精确布置回路管子到光学传感器例如Optek传感器中,当歧管被安装并且门关闭时所述传感器单独安装在仪器中。 Referring back to Figure 3a, the manifold 300 includes a plurality of tube support brackets 322, which facilitates precise placement of the tubes to the optical sensor circuit Optek sensor e.g., when the manifold is installed and the door is closed when the sensor is mounted in a separate instrument. 传感器提供用于检测动脉线路中的梗塞,透析器下游的血液线路中的血液泄漏和静脉血液线路中的空气检测的装置。 Sensors detecting the arterial line infarction, leakage of blood or blood line downstream of the dialyzer and the venous blood line means for detecting air. 支架限制管子在传感器的一个侧面上,而管子端口进行在传感器的另一侧面上的限制。 Limiting tube holder on one side of the sensor, while limiting the tube port on the other side of the sensor. 这些光学传感器是U形制造,当安装歧管时管子迫压到U形装置中。 The U-shaped optical sensors are manufactured, when the manifold is mounted to the U-shaped tube pressing device. 管子支撑支架提供对管子的支撑以使得全部的这三个传感器在装载歧管时通过相同的运动进行装载,不需要用户部分的额外的努力。 Tube support bracket provides support for the tube so that all these three extra effort load sensor, the same user is not required by the portion of the manifold during the loading movement.

[0129] 如更早前提及的,本发明的体外血液处理系统实施为便携人工肾(PAK),其能够根据需要在血液透析或者血液过滤构型中进行操作。 [0129] The afore-mentioned earlier, extracorporeal blood treatment system of the present invention is implemented as a portable artificial kidney (PAK), which is capable of operating in hemodialysis or hemofiltration configuration as needed. 为了允许用户选择期望的操作模式(血液透析或者血液过滤),在一个实施例中,系统设置有双路阀。 To allow the user to select a desired mode of operation (hemodialysis or hemofiltration), in one embodiment, the system is provided with a two-way valve. 这些阀可以通过用户促动以要么在一个操作模式中导向透析液流动通过透析器,要么在第二操作模式中递送注入液级的透析液直接流动到患者。 These valves can be actuated by a user to guide either dialysate flow through the dialyzer in one mode of operation, or in a second operating mode to deliver infusate stage dialysate flow directly to the patient. 这些双路阀还可以集成有透析回路的紧凑歧管。 These two-way valves may also be integrated with a compact manifold dialysis circuit. 这示出在图6a中,应当注意到,在图6a_6e中,为了清楚的目的,相应的元件具有相同的标记。 This is illustrated in Figure 6a, it should be noted that, in FIG 6a_6e, for purposes of clarity, corresponding elements have the same numerals.

[0130] 参照图6a,体外血液处理系统600包括塑料模制的紧凑歧管610,其封套多个模制的血液和透析液流体路径以及多个传感器、阀和流体泵。 [0130] Referring to FIG 6a, extracorporeal blood processing system 600 comprises a compact plastic molded manifold 610, which envelopes the plurality of molded blood and dialysate fluid path and a plurality of sensors, valves and the fluid pump. 透析器605在当连接到歧管610的动脉血管601和静脉血管602时完成系统600的血液回路。 The system is completed when the blood circuit 600 when the dialyzer 605 is connected to the artery 601 and vein 602 of the manifold 610. 在一个实施例中,透析器605是一次性的。 In one embodiment, the dialyzer 605 is a disposable. 两个线路603和604用于分别循环用过的和新的透析液。 Two lines 603 and 604, respectively, for circulating the used and new dialysate. 为了以两种模式(血液透析和血液过滤)的任一操作系统600,提供双路阀645和备用双路阀646。 For both modes (hemodialysis and hemofiltration) according to any one operating system 600 to provide two-way valves 645 and 646 alternate two-way valve. 备用阀646被采用,因为在血液透析中使用的透析液没有消毒并且不是充灌等级的,而在血液过滤中使用的流体是消过毒并且是充灌等级的。 Alternate valve 646 is used because the dialysate used in hemodialysis is not sterilized and not filling level, the fluid used in the blood filter is sterile and filling is level. 在血液透析模式中操作以及阀645泄漏或者其它的故障的情形下,阀646提供双重保护,防止流体泵送到患者血流中。 And a valve operating case 645 in hemodialysis mode leak or other failure, the valve 646 provides double protection against fluid pumped into the patient's bloodstream. 包括备用阀646允许一个歧管安全地用于血液透析和血液过滤二者。 Including both hemodialysis and hemofiltration a manifold allows for the safe backup valve 646. 如上面注意到的,双路阀例如备用阀646是由两个单一阀构成。 As noted above, alternate two-way valve 646 is a valve for example composed of two single valves. 在这种情况中,两个单向阀串联,并因此通过闭合双路阀646的两个端口,能够进行双重保护,防止透析液进入血流中。 In this case, two one-way valves in series, and thus the valve port 646 by closing the two-way, double protection can be performed to prevent the dialysate into the blood stream. 在替代实施例中,歧管可以被制造来仅用于血液透析,从而在透析流体回路和血液回路之间连接,并且阀646得以安全地消除。 In an alternative embodiment, the manifold may only be made to hemodialysis, so connection between the dialysis fluid circuit and a blood circuit, and the safety valve 646 is eliminated.

[0131] 图6b示出用于根据本发明的血液透析/血液过滤系统的回路的进一步的细节。 [0131] Figure 6b illustrates further details of a circuit according to the present invention hemodialysis / hemofiltration system. 参照图6b,用过的透析液和新的透析液管603和604分别连接到透析液再生系统606,从而完成系统600的透析液回路。 Referring to Figure 6b, the spent dialysate and the dialysate new tubes 603 and 604 are connected to a dialysate regeneration system 606, thereby completing the dialysate circuit system 600. 透析液再生系统606进一步包括一次性吸附剂盒615和储存器634以保持通过盒615纯化的透析液。 Dialysate regeneration system 606 further comprises a disposable sorbent cartridge 615 and the reservoir 634 to hold cartridge 615 purified by the dialysate. 如图6b所示的系统的其它的部件以及它们的功能参照图6c进行解释,图6c示出配置来在血液透析模式中操作的体外血液处理系统600的分解视图。 Other components of the system shown in Figure 6b and Figure 6c their functions will be explained with reference to, Figure 6c shows an exploded view of a configuration of the extracorporeal blood processing systems operating in hemodialysis mode 600. 在图6b和6c中对应元件具有相同的附图标记。 Corresponding elements in FIGS. 6b and 6c have the same reference numerals.

[0132] 参照图6b和6c,具有两个流体回路-血液回路620和透析液回路625。 [0132] Referring to Figures 6b and 6c, having two fluid circuits - 620 blood circuit and the dialysate circuit 625. 血液回路620包括沿着管601抽取患者的动脉的不纯血液并泵送血液通过透析器605的蠕动血液泵621。 620 impure blood circuit comprising the arterial blood of a patient drawn along the tube 601 and pump blood through the dialyzer 605 621 a peristaltic blood pump. 注射器装置607注射抗凝血剂例如肝素到抽取的不纯的血流中。 Injection of the injector device 607, for example, anticoagulant heparin impure blood flow in the extraction. 压力传感器608布置在血液泵621的入口处,而压力传感器609和611布置在透析器605的上游和下游以监测在这些优势点的压力。 The pressure sensor 608 is arranged at the inlet of the blood pump 621, the pressure sensors 609 and 611 arranged upstream and downstream of the dialyzer 605 to monitor the pressure at those points advantages. 因为提纯的血液在透析器605下游流动并回到患者,血液温度传感器612设置在线路中以跟踪提纯的血液的温度。 Because the purified blood temperature in the dialyzer 605 and the downstream flow back to the patient, blood temperature sensor is disposed in the line 612 to track blood purification. 空气消除器613同样被提供以从透析器移除积聚在清洁血液中的气泡。 Air eliminator 613 are likewise provided to remove air bubbles from the dialyzer blood accumulated in the cleaning. 一对空气(气泡)传感器(或者任选地单一的传感器)614和夹捏阀616用在回路中以防止积聚的气体返回到患者。 A pair of air (bubbles) sensor (or optionally a single sensor) 614 and a pinch valve 616 used in the circuit to prevent the accumulation of gas returned to the patient.

[0133] 透析液回路625包括两个双通道透析液泵626、627。 [0133] The dialysate circuit 625 includes two dual-channel dialysate pump 626, 627. 透析液泵626、627从透析器605抽取用过的透析液溶液,并从储存器634抽取再生的透析液溶液。 626, 627 pump spent dialysate from the dialyzer 605 extracts the dialysate solution, and dialysate solution from the reservoir 634 to extract reproduced. 在来自透析器605的用过的透析液流体进入透析液回路602的点上,血液泄漏传感器628被设置以传感和防止任何到透析液回路中的血液泄露。 Point in the spent dialysate from the dialyzer fluid 605 enters the dialysate circuit 602, and blood leak sensor 628 is provided to sense and prevent any leakage of blood into the dialysate circuit. 来自透析器605的出口的用过的透析液然后通过旁通阀629以抵达双路阀630。 Spent dialysate from the dialyzer outlet 605 and then through the bypass valve 629 to reach the two-way valve 630. 压力传感器631布置在阀629和630之间。 The pressure sensor 631 is disposed between the valve 629 and 630. 超滤液泵632设置在透析液回路中,其定期操作以从用过的透析液抽取超滤液废物并将其储存在超滤液袋633中,超滤液袋633被定期排空。 Ultrafiltration pump 632 is provided in the dialysate circuit, which is periodically operative to extract ultrafiltrate waste from the spent dialysate and the ultrafiltrate are stored in the bag 633, the bag 633 ultrafiltrate is periodically emptied.

[0134] 如以前提及的,用过的透析液通过利用吸附剂盒进行再生。 [0134] As mentioned before, by using the spent dialysate sorbent cartridge for regeneration. 通过吸附剂盒615再生的透析液收集在储存器634中。 A dialysate sorbent cartridge 615 by regeneration collected in the reservoir 634. 储存器634分别包括电导率和氨传感器661和662。 Reservoir 634 include ammonia and conductivity sensors 661 and 662. 从储存器634,再生的透析液通过节流器635和压力传感器636以抵达双路阀637。 From the reservoir 634, the regenerated dialysate through restrictor 635 and a pressure sensor 636 to reach the two-way valve 637. 取决于患者的要求,期望量的来自储存器650的注入液溶液和/或来自储存器651的浓缩溶液可以加入到透析流体。 Depending on the requirements of the patient, the desired amount of liquid injection solution from the reservoir 650 and / or the concentrated solution from the reservoir 651 may be added to the dialysis fluid. 注入液和浓缩液是包含矿物和/或葡萄糖的消毒溶液,其帮助保持透析液流体中的矿物质例如钾和钙在医师规定的水平。 Injection and a concentrate comprising a mineral and / or disinfecting solution of glucose, which helps maintain the dialysate fluid minerals such as potassium and calcium levels in the predetermined physician. 旁通阀641和蠕动泵642被提供以选择期望量的注入液和/或浓缩溶液并保证溶液适当地流动到从储存器634流出的纯化的透析液。 Bypass valve 641 and peristaltic pump 642 is provided to select a desired quantity of injection fluid and / or concentrated solution and to ensure proper flow to a solution of the purified effluent dialysate from the reservoir 634.

[0135] 透析液回路包括两个双路阀630和637。 [0135] The dialysate circuit comprises two two-way valves 630 and 637. 阀630导向用过的透析液的一个流到透析液泵626的第一通道,用过的透析液的另一个流到透析液泵627的第一通道。 Valve guide 630 spent dialysate flowing a first dialysate pump passage 626, the other spent dialysate flowing in the dialysate pump 627 of the first passage. 类似地,阀637导向再生的透析液的一个流到透析液泵626的第二通道,再生的透析液的另一个流到透析液泵627的第二通道。 Similarly, the valve guide regenerated dialysate 637 flows to a second channel of the dialysate pump 626, another regenerated dialysate flow to the second passage 627 of the dialysate pump.

[0136] 来自泵626和627的用过的透析液的流通过双路阀638收集,而来自泵626和627的再生的透析液的流通过双路阀639收集。 [0136] Flow from the dialysate pumps 626 and 627 are used by the two-way valve 638 was collected, and the flow from the pump 626 and a dialysate regeneration by the two-way valve 627 to collect 639. 阀638组合用过的两个透析液流为单一流,该单一流经由压力传感器640泵送,并通过吸附剂盒615,在那里用过的透析液被纯化和过滤,收集在储存器634中。 The combination valve 638 to the spent dialysate two single stream, which is pumped by the single pressure sensor 640 flows through, and, where the spent dialysate is purified and filtered through a sorbent cartridge 615, 634 collected in the reservoir . 阀639组合再生透析液的两个流为单一流,该单一流通过旁通阀647流动到双路阀645。 Two valves 639 regenerated dialysate composition is a single class, the single stream flows to the two-way valve 645 through the bypass valve 647. 压力传感器643和透析液温度传感器644设置在到双路阀645的透析液流动流上。 Dialysate pressure sensor 643 and temperature sensor 644 disposed on the two-way valve 645, the dialysate flow stream.

[0137] 通过颠倒双路阀630、637、638和639的状态,两个泵626和627在它们的动作方面反过来,一个从透析器605抽出透析流体,另一个供应透析流体到透析器605。 [0137] state by reversing the two-way valves 630,637,638 and 639, two pumps 626 and 627, in turn, a dialysis fluid from the dialyzer 605 drawn in terms of the operation thereof, supplying the dialysis fluid to the dialyzer another 605 . 这样的反向在当相对于透析部分端时间地定期进行时,保证整个透析部分的更长的期间上泵送到透析器中的透析液流体体积等于泵送出去的流体量并且仅通过透析回路625拾取的总的流体体积是通过超滤液泵632移除的体积。 Such partially reversed when the end time of dialysis regular manner with respect to the amount of fluid to ensure that the pump volume of the dialyzer dialysate fluid pumped out is equal to the longer period throughout the dialysis portion and only by the dialysis circuit the total volume of fluid pickup 625 is removed by ultrafiltration volume pump 632.

[0138] 在血液透析模式中,如图6c所示,双路阀645允许再生透析液进入透析器605中以使得患者的血液能够正常血液透析。 [0138] In the hemodialysis mode, as shown in FIG. 6C, two-way valve 645 allows the regenerated dialysate into the dialyzer 605 so that the blood of a patient can be normal hemodialysis. 阀645的一侧闭合,从而通向患者的血液返回线路。 Side of the valve 645 is closed so that the return line leading to the patient's blood. 另一个双路阀646用作替补,从而保持透析液形成患者的血液线路,即便阀645泄漏或者失效,阀646的两个端口都闭合。 Another two-way valve 646 is used as a substitute, so as to maintain the patient's blood dialysate line is formed, even if the leak or failure of the valve 645, the two-port valve 646 are closed.

[0139] 在血液过滤操作模式中,如图6d所示,双路阀645可以被促动以导向来自储存器652的新的超高纯的透析液的流通过阀646,此刻两个端口都打开以直接进入从透析器出来并流回患者的提纯血液的流中。 [0139] In the blood filtering operation mode, as shown in FIG. 6D, two-way valve 645 may be actuated to guide the flow from the reservoir new ultra high purity dialysate valve 646 by 652, are at the moment two ports to open directly into the dialyzer and back out of the blood stream of a patient purification.

[0140] 本领域技术人员应当注意到,备用双路阀646是冗余的安全阀以保证在血液透析模式中一个阀645的失效不会导致再生的透析液直接充灌到患者中。 [0140] It should be noted that those skilled in the art, alternate two-way valve 646 is a redundant safety valve to ensure that a hemodialysis mode valve 645 does not result in failure of the regenerated dialysate into the patient directly filling. 也就是,出于安全的考虑,两个阀645和646都能够由用户促动以允许流体导向到患者的静脉血液线路。 That is, for safety reasons, two valves 645 and 646 can be actuated by the user to allow fluid to a patient's venous blood guide line. 在一个实施例中,两路备用阀646是单一的阀允许或者停止流体流动。 In one embodiment, the two-way valve 646 is a single spare valves allow or stop the flow of fluid.

[0141] 本领域技术人员应当进一步注意到,在上面描述的阀称作“旁通”或者“两路”,其取决于它们的使用。 [0141] Those skilled in the art should further be noted that the valve described above is called a "pass" or "two-way", depending on their use. 这样,当阀旁通一些东西例如透析器时它们称作“旁通阀”。 Thus, when the bypass valve is something which e.g. dialyzer referred to as "bypass valve." 否则,它们称作“双路阀”并简单地在至少两个方向导向流动。 Otherwise, they are referred to as "two-way valve" and simply guided to flow in at least two directions. 但是,旁通和双路阀在结构上是相同的。 However, the two-way valve and the bypass are identical in structure.

[0142] 在一个实施例中,用于本发明的双路阀制造为弹性膜,其抵靠着口由包含在透析设备内部的机构挤压以停止具有与流体回路的剩余部分接触的流体的流。 [0142] In one embodiment, a two-way valve of the present invention for producing an elastic film, which comprises pressing against the inside of the mouth of the dialysis apparatus having a mechanism to stop the fluid in contact with the remaining portion of the fluid circuit flow.

[0143] 如提及的,双路阀645和646能够用于改变用于血液处理系统的操作模式。 [0143] As mentioned, the two-way valves 645 and 646 can be used for changing the operation mode of the blood processing system. 图6d示出一实施例,其中系统600配置为在血液过滤规程下操作。 Figure 6d shows an embodiment in which the system 600 is configured to operate in a hemofiltration procedure. 参照图6d,在血液和透析液回路620和625中的流体流动被描述。 Referring to FIG. 6d, the blood and fluid flow in the dialysate circuit 620 and 625 are described. 因为所述系统是在血液过滤模式下操作,因此用过的透析液管603连接到排出口,而新的透析液管604连接到新的超高纯的和可注射等级的透析液储存器652。 Since the system is operating in hemofiltration mode, the spent dialysate is connected to the outlet pipe 603, and the new dialysate tube 604 is connected to a new ultra high purity grade and injectable dialysate reservoir 652 . 通过球体阀排出室653的新的透析液通过加热器袋654以流入新的透析液管604中。 New dialysate discharge chamber 653 through the ball valve to a new dialysate flows through the heater tube 604 bags 654. 其余元件以及血液和透析液回路620、625的流体路径与图6c的那些相似,除了当用过的透析液被排出并且不再使用时在血液过滤规程中新的透析液或者更换的流体被引入透析液回路625中之外。 Remaining elements and a blood circuit and the dialysate fluid path 620, 625 similar to those in FIG. 6c, except when discharged spent dialysate and no new replacement fluid or dialysate in the blood is introduced into the filtration procedure when used dialysate circuit 625 outside. 通过图6d中的灰色阴影表示的是,在血液过滤模式中,结合部件642、650、641和651的注入液子系统并不使用。 Represented by shades of gray in FIG. 6d, in blood filtration mode, and a coupling member 642,650,641 injection fluid subsystem 651 is not used.

[0144] 参照图6d,血液回路620包括蠕动血泵621,其沿着管601抽取患者的动脉的不纯血液并泵送血液通过透析器605。 [0144] Referring to FIG. 6D, the blood circuit 620 comprises a peristaltic blood pump 621, the tube 601 along the patient's arterial blood draw impurities and pump blood through the dialyzer 605. 任选的泵607注入抗凝血剂,例如肝素,到抽取的不纯的血流中。 Optional pump 607 is injected anticoagulant, such as heparin, to the extraction of the impure blood. 压力传感器608不再在血泵621的入口处,而压力传感器609和611布置在透析器605的上游和下游。 The pressure sensor 608 is no longer in the inlet of the blood pump 621, the pressure sensors 609 and 611 arranged upstream and downstream of the dialyzer 605. 来自透析器605的提纯的血液泵送通过管602,通过血液温度传感器612、空气消除器613和空气(气泡)传感器614并回到患者的静脉。 The purified blood from the dialyzer 605 through the tube 602 is pumped by the blood temperature sensor 612, an air eliminator 613 and the air (bubbles) sensor 614 and back into the patient's vein. 夹捏阀616同样被布置以如果在夹捏阀616的上游的线路中的气泡传感器614传感到空气就停止血液流动,从而防止空气抵达患者。 Pinch valve 616 is disposed in the same line if the air bubble sensor 614 upstream of the valve 616 in the pinch of the sensed air flow of blood is stopped, thereby preventing the patient arrived in the air.

[0145] 透析液回路625包括两个双通道透析液泵626、627。 [0145] The dialysate circuit 625 includes two dual-channel dialysate pump 626, 627. 透析液泵626、627分别从透析器605抽取用过的透析液溶液和从储存器652抽取新的透析液溶液。 626, 627 new dialysate pump dialysate solution from the dialyzer 605 to extract the spent dialysate solution and extracted from the reservoir 652, respectively. 来自透析器605出口的用过的透析液被抽取通过血液泄漏传感器628和旁通阀629以抵达双路阀630。 Spent dialysate from the dialyzer outlet 605 is drawn through the blood leak sensor 628 and the bypass valve 629 to reach the two-way valve 630. 压力传感器631布置在阀629和630之间。 The pressure sensor 631 is disposed between the valve 629 and 630. 超滤液泵632定期操作以从用过的透析液抽取超滤液废物并储存在超滤液袋633 (其定期排空)中。 Ultrafiltration pump 632 operates to periodically extracted from spent dialysate ultrafiltrate waste bags and stored in the ultrafiltrate 633 (which is periodically emptied) in. 来自储存器652的新的透析液通过节流器635和压力传感器636以抵达双路阀637。 New dialysate from the reservoir 652 through the orifice 635 and pressure sensor 636 to reach the two-way valve 637. 本领域技术人员将认识到,在该规程中,注入液和浓缩液不是必需的,相应地,与那些功能相关的元件641、642、650、651示出为“被灰掉”。 Those skilled in the art will recognize that, in this procedure, the injection and a concentrate is not necessary, accordingly, associated with those functional elements 641,642,650,651 shown as "is grayed out." 在图6e的流体图形中,双路阀641以及泵642表示为灰色的,从而表明它们并不处于在用中,而是为图6a的公共的歧管610的一部分。 Figure 6e in the fluid pattern, the two-way valve 641 and the pump 642 is expressed as gray, indicating that they are not in use in, a portion of tube 610 but a common manifold of Figure 6a.

[0146] 加热器袋654充分地升高新的透析液的温度以使得从透析器605回到患者的超滤器血液的温度或者来自透析器605的超滤器血液和通过促动阀645、646直接充灌到提纯的血液中的新的透析液的混合物的总温度相当于患者的身体温度,从而防止任何热冲击。 [0146] heater bag 654 sufficiently elevated new temperature so that the dialysate from the dialyzer 605 back to patient blood temperature ultrafilter or ultrafilters from hemodialysis and 605 by actuating the valves 645, 646 direct filling mixture new dialysate to the blood purification temperature corresponds to the total body temperature of the patient, thereby preventing any thermal shock.

[0147] 图6e示出其中图6a_6c的备用双路阀646并不在用的流体装置的替代实施例。 [0147] Figure 6e illustrates an example in which two-way valve 646 6a_6c FIG spare not In an alternative embodiment of a fluidic device. 现参照图6e,血液回路包括蠕动血泵621,其沿着管601抽取患者的动脉不纯血液并泵送血液通过透析器605。 Referring now to FIG. 6E, the blood circuit comprising a peristaltic blood pump 621, which extracts the patient's arterial blood and impure pump blood through the dialyzer 605 along the tube 601. 泵607注射抗凝血剂例如肝素到抽取的不纯血流中。 Injection pump 607, for example, an impure blood anticoagulant to drawn in heparin. 压力传感器608布置砸死血泵的入口处,而压力传感器609和611布置在透析器605的上游和下游。 The pressure sensor 608 is arranged killed blood inlet of the pump, the pressure sensors 609 and 611 arranged upstream and downstream of the dialyzer 605. 来自透析器605的提纯的血液泵送通过管602,通过血液温度传感器612、空气消除器613和空气(气泡)传感器614并回到患者的静脉。 The purified blood from the dialyzer 605 through the tube 602 is pumped by the blood temperature sensor 612, an air eliminator 613 and the air (bubbles) sensor 614 and back into the patient's vein. 在连接到患者的回路之前还布置夹捏阀616以如果空气被夹捏阀616的线路上游中的空气(气泡)传感器614传感到就完全停止血液流动,从而防止空气抵达患者。 Before connecting to the patient circuit is further arranged to pinch valve 616 if the nip line is upstream of the air valve 616 in air (bubbles) sensor 614 sensed blood flow is completely stopped, thereby preventing the patient arrived in the air.

[0148] 透析液回路包括两个透析液泵626、627。 [0148] dialysate circuit comprises a dialysate pump 626, 627 two. 透析液泵626、627分别从透析器605抽取用过的透析液溶液和从储存器634抽取再生透析液溶液。 626, 627 are regenerated dialysate pump dialysate from the reservoir 634 solution is withdrawn from the dialyzer 605 to extract and spent dialysate solution. 来自透析器605的出口的用过的透析液被抽取通过血液泄漏传感器628以抵达旁通阀629。 From the outlet of the dialyzer 605 is withdrawn spent dialysate through the blood leakage sensor 628 to reach the bypass valve 629. 流动传感器630是两个流动传感器的一个(另一个是流动传感器646),其确定流动通过回路的透析液的体积。 The flow sensor 630 is a two flow sensors (the other being a flow sensor 646), which determines the volume of the dialysate flowing through the circuit. 阀630'在结构上类似于双路阀并用到旁通透析液泵626。 Valve 630 'is similar in structure and use two-way bypass valve dialysate pump 626. 阀630'一般在旁通方向闭合。 Valve 630 'is generally the direction of closing the bypass. 在停止透析液泵626的情形下,阀630'打开以导向泵626周围的流动。 In the case of stopping the dialysate pump 626, valve 630 'is opened to guide the flow around the pump 626. 压力传感器631布置在流动传感器630和阀630'之间。 The pressure sensor 631 is disposed between the flow sensor 630 and valve 630 '. 在正常流动过程中,用过的透析液经由压力传感器泵送,并通过吸附剂盒615,在那里用过的透析液被纯化和过滤。 In the normal flow process, the spent dialysate is pumped via the pressure sensor, and by the sorbent cartridge 615, where the spent dialysate is purified and filtered. 纯化/过滤的透析液然后进入储存器634。 Dialysate purification / filtration then enters the reservoir 634. 超滤液泵632定期操作以从用过的透析液抽取超滤液废物并存储在超滤液袋(未示出)中,该超滤液袋定期排空。 Ultrafiltration pump 632 operates to periodically extract ultrafiltrate waste from the spent dialysate and the ultrafiltrate stored in the bag (not shown), the ultrafiltrate periodically emptying the bag.

[0149] 来自储存器634的再生透析液通过节流器635、透析液温度传感器644、流量传感器646和压力传感器636以通过旁通阀641抵达双路阀645。 [0149] regenerated dialysate from the reservoir 634 through the orifice 635, the dialysate temperature sensor 644, flow sensor 646 and pressure sensor 636 to reach the two-way valve 645 through the bypass valve 641. 当旁通阀629和645和641的各流动路径被促动时,它们导向再生的透析液以绕过透析器605。 When each bypass valve 629 and the flow paths 645 and 641 are actuated, they guide the regenerated dialysate to bypass the dialyzer 605. 来自注入液和浓缩液储存器650、651的注入液和浓缩液流通过注入液和浓缩液泵642、643分别导向到从储存器634出来的纯化的透析液和流量传感器630下游的用过的透析液中。 Infusate from infusate reservoir 650, 651 and a concentrate and a concentrate stream 630 directed to the purified dialysate and a flow sensor downstream from the reservoir 634 out through liquid injection pump 642, 643 respectively and concentrated spent dialysate.

[0150] 双路阀645确定系统600在什么模式操作。 [0150] two-way valve 645 determines what mode the system 600 in operation. 这样,在一个操作模式中,双路阀645允许再生的透析液进入透析器以使得能够正常地血液透析患者的血液。 Thus, in one mode of operation, the two-way valve 645 allows the dialysate regeneration enters the blood dialyzer to enable normal hemodialysis patients. 在另一个操作模式中,双路阀645被促动以导向超高纯的注入液等级的透析流体的流体流动到静脉血线路中并直接到患者。 In another mode of operation, two-way valve 645 is actuated to direct the fluid in the dialysis fluid ultrapure liquid level flows into the injection line and venous blood directly to the patient. 相应地,多功能阀使得操作模式能够在血液过滤和血液透析之间切换。 Accordingly, the multifunction valve so that the operation mode can be switched between the blood and the hemodialysis filter. 例如,在如图6d所示的血液过滤中,可充灌等级的流体传输通过直接在血流中三个阀,在那里阀646连接到后透析器。 For example, the blood filter shown in FIG. 6d, the filling level of fluid in the blood stream directly transmitted through three valve, where the valve 646 is connected to the dialyzer. 在这个模式中,阀645防止透析液流体进入到透析器的下端口。 In this mode, the valve 645 prevents fluid from entering the dialysate port of the dialyzer. 在血液透析中,如图6c所示,阀646闭合而阀647和645传输透析液流体到透析器。 In hemodialysis, shown in Figure 6c, the valve 646 is closed while valves 647 and 645 transmit fluid to the dialyzer dialysate.

[0151] 应当注意到,尽管图6c和6e的实施例表不两个不同的流动控制构思。 [0151] It should be noted that although FIGS. 6c and 6e embodiment tables are not two different flow control concepts. 尽管图6c的实施例使用泵交换和多个阀以控制流体容器,图6e的实施例使用流动传感器630和646以控制流体体积。 Although the embodiment of Figure 6c using a pump and a plurality of switching valves to control the fluid container embodiment of FIG. 6e Example 630 and 646 using a flow sensor to control fluid volume.

[0152]用于血液透析系统的流体回路的歧管的使用使得透析单元(便携人工肾或者PAK)能够为模块化的和便携的,具有改进的功能性。 [0152] a manifold for a fluid circuit such that the hemodialysis system dialysis unit (artificial kidney or a portable PAK) are modular and can be portable, having improved functionality. 歧管可以制造为单独的单元,该单元可以容易地安装到透析单元中。 The manifold may be manufactured as a separate unit which can be easily mounted to the dialysis unit. 图7示出其中血液和透析液回路是完全一次性的并包装在套件700中的实施例。 Figure 7 shows a circuit in which the blood and the dialysate is completely disposable and packaged in the kit in Example 700. 套件包括透析器701、歧管702、管子703、阀704(作为歧管的一部分)、储存器袋705和其它的一次性部件。 Kit includes dialyzer 701, manifold 702, pipe 703, valve 704 (as part of the manifold), the reservoir 705 bags and other disposable components.

[0153] 图8示出安装在透析设备中的歧管。 [0153] FIG. 8 shows the manifold installed in the dialysis apparatus. 参照图8,透析设备801具有前门803,其能够宽地打开以安装一次性部件。 Referring to FIG. 8, the dialysis apparatus 801 has a front door 803, which can be opened wide for mounting a disposable member. 对于安装,歧管804简单地需要插入在为了塑身目的在透析单元801中提供的空间中。 For installation, the manifold 804 simply needs to be inserted in the space provided for the purpose of shaping unit 801 in the dialysis. 安装透析器802还包括简单插入指定的凹陷中。 Installation dialyzer 802 further includes a specified simple insertion recess. 前门803设置有泵靴,其使得一次性部件的装载非常容易,因为不需要泵管子来在辊和靴之间螺纹连接。 Front shoe 803 is provided with a pump, which makes the disposable loading member is very easy, since no pump tubing to a threaded connection between the roller and the shoe. 进一步地,该配置允许以保证正确对齐非一次性部件例如压力读取器、传感器及其他部件的方式安装透析器802和歧管804。 Further, this arrangement allows to ensure the correct alignment of the non-disposable components, for example, of a pressure readers, sensors and other components mounted dialyzer 802 and the manifold 804. 该包装的简单的方法使得能够容易地处理装载并清洁系统。 Simple method of the package makes it possible to easily handle the loading and cleaning systems. 还保证流动线路正确配置并易于使用。 But also to ensure the flow line is properly configured and easy to use.

[0154] 本发明可以至少在两个不同模式进行操作:充灌模式和治疗模式,其能够包括其它的操作模式(例如血液透析、血液过滤或者简单地非充灌模式)。 [0154] The present invention can be operated in at least two different modes: filling mode and treatment mode, which can include other modes of operation (e.g. hemodialysis, hemofiltration or simply non-filling mode). 关于示例性的治疗模式并同时参照图4和图10,在透析模式操作的透析系统1000包括透析器1002、430、吸附剂再生系统(例如盒)1012、歧管1010、400、通过端口M 425进入歧管1010、400中的注入液或者透析液源1016和储存器1015,新的透析液经由端口E 419从储存器1015输入回到歧管1010,400ο在操作中,血液进入血液线路1001中,通过端口C 417进入歧管1010、400中,通过处于第一位置的双路阀1021,并进入到透析器1002中。 About exemplary treatment mode and with reference to FIGS. 4 and 10, the dialysis system in a dialysis mode of operation 1000 1002,430, regeneration of the adsorbent system (e.g., cassette) comprising a dialyzer 1012, 1010,400 manifold, M 425 via port into the injection fluid in the manifold 1010,400 dialysate source or reservoir 1016 and 1015, the new dialysate back from the reservoir 1015 via input port manifold E 419 1010,400ο in operation, blood enters the blood line 1001 , C enters through the port 417 in the manifold 1010,400, through two-way valve 1021 is in the first position, and into the dialyzer 1002. 提纯的血液退出透析器1002、430,处于第一位置的通过双路阀1022,并通过端口G 421进入到歧管1010、400中。 The purified blood exits the dialyzer 1002,430, in the first position by the two-way valve 1022, and into the manifold through port 1010,400 G 421. 血液通过歧管,通过多个阀,如上面关于歧管400、1010描述的,并从端口H 422出来并进入血液线路1023中,从而进入患者中。 Blood through the manifold, through a plurality of valves, as described above with respect to the manifold 400,1010, and out of the port into the blood line H 422 and 1023, thereby entering the patient.

[0155] 同时,从源1016通过的注入液或者透析液通入到歧管1010、400中,通过端口M425,通过歧管,通过端口F 420出来,进入到透析液内部线路1024中并进入到透析器1002、430中。 [0155] Meanwhile, the injection fluid from the source through the 1016 or the dialysate into the manifold 1010,400 by M425 port, through the manifold, through port F 420 out and into the dialysate line 1024 and into the interior of the 1002,430 in the dialyzer. 在通过透析器1002之后,透析液通过外线路1025并通过端口B 416回到歧管1010、400中,在那里,透析液经由端口N 426传输到基于吸附剂的透析液再生系统1012。 1002 after passing through the dialyzer, the dialysate line 1025 through the outer ports B and back through the manifold 416 1010,400, where the dialysate is transferred to the dialysate regeneration system 1012 via port-based sorbent N 426. 再生的透析液经由端口E 419向后通过歧管1010、430并用新的透析液再循环通过透析器1002、430,如需要的话和当需要时。 Then regenerated dialysate via port E 419 rearwardly through the manifold 1010,430 and recycled with fresh dialysate through the dialyzer 1002,430, if required and when needed. 为了管理透析液流,储存器1015用于存储再生透析液,如果需要的话和当需要时。 For dialysate flow management, the storage 1015 for storing regenerated dialysate, if desired, and when it is necessary. 在一个实施例中,储存器容纳5公升的透析液并具有保持高达10公升的透析液和来自患者的流出物的容量。 In one embodiment, the reservoir containing the dialysate and 5 liters of a holding of up to 10 liters of dialysate and the capacity of the effluent from the patient.

[0156] 关于示例性的充灌模式并同时参照图4和图11,在充灌模式操作的透析系统1100包括透析器1102、430、吸附剂再生系统(例如盒)1112、歧管1110、400、注入液源1116和储存器1115。 [0156] For exemplary filling mode and with reference to FIG. 4 and FIG. 11, in a filling mode of operation of the dialysis system comprises a dialyzer 1102,430 1100, sorbent regeneration system (e.g., cassette) 1112, 1110,400 manifold , infusate source 1116 and the reservoir 1115. 在操作中,从患者(例如图10中的1001)到歧管1110、430中的血液线路并不连接并且因此没有血液流动,或者能够流动,通过端口C 417进入歧管1110、400。 In operation, the manifold 1110,430 is not connected to the blood line from the patient (e.g., 1001 in FIG. 10) and thus no blood flow, or able to flow into the manifold through the port C 417 1110,400. 而是,从源1116通过的透析液通过端口M 425通入歧管1110、430,通过端口B 416出来,并通过透析液内部线路1124,该线路1124连接到双路阀端口1122。 Rather, the dialysate from the source 1116 pass through the port into the manifold M 425 1110,430, out through port B 416, and the internal dialysate circuit 1124, the line 1124 is connected to the dual port valve 1122.

[0157] 在优选实施例中,单一双路阀结合到歧管的物理主体中并且操控以在治疗操作模式和充灌操作模式之间切换。 [0157] In a preferred embodiment, a single two-way valve is coupled to the physical body of the manifold and manipulated to switch between the operation mode and a treatment mode of filling operation. 在这个实施例中,歧管包括双路阀,其如果从第一位置(例如闭合)被促动或者切换到第二位置(例如打开)导致到在歧管内的液体内部流动路径的变化。 In this embodiment, the manifold includes a two-way valve if (e.g., closed) to be actuated from a first position to a second position or switch (e.g. open) leads to a change in the liquid flow path in the interior of the manifold. 由于该流动路径变化,血液和透析液回路,其在当阀闭合时彼此流体隔离,现在布置为彼此流体连通。 Since the flow path changes, the blood and dialysate circuit, which valve is closed when the fluid isolated from one another, are now disposed in fluid communication with each other. 优选地,不需要其它的阀或者开关来操控以为了实现该状态变化,也就是使得单独的血液和透析液回路变成流体连接的。 Preferably, no additional control valve or switch the realization that the state change, i.e. such that the separate blood and dialysate circuit becomes fluid connection.

[0158] 阀切换可以通过现有技术已知的任何方式实行,包括通过物理操控在歧管的表面上的机械控制器,或者通过操作透析设备而进行电子操控,从而导致通过透析设备和阀接口之间的接口转变阀状态,其中所述透析设备具有控制器以根据用户选择的操作模式控制阀的状态,所述阀接口集成到歧管的表面中。 [0158] Valve switching may be implemented by any means known in the art, including by mechanical manipulation of the controller on the physical surface of the manifold, or by operating the electronically controlled dialysis machine, the dialysis equipment and by causing valve interface the interface between the transition state of the valve, wherein said dialysis apparatus having a controller according to the state of the control valve operation mode selected by the user, integrated into the valve interface surface of the manifold. 在一个实施例中,本发明形成双稳态的磁驱动阀,如在于2009年I月12日提交的美国专利申请N0.12/351,969中公开的,该专利申请在此被引入作为参考。 In one embodiment, the present invention is formed of a bistable magnetic drive valve, such as that U.S. Patent 12 February 2009 I filed N0.12 / 351,969 disclosed in this patent application is incorporated herein by reference.

[0159] 在优选实施例中,透析设备包括接口,其为具有触摸屏按钮、物理键盘或者鼠标的图形用户截面,其可以被操控以使得装载有歧管的如图8和9所示的透析设备在治疗模式或者充灌模式中开始操控。 [0159] In a preferred embodiment, the dialysis apparatus includes an interface, which is having a touch screen button or graphical user sectional physical keyboard mouse, which can be manipulated such that loaded with the manifold 8 and 9 dialysis equipment in the treatment mode or start filling mode control. 当指示在治疗模式中操作时,控制器产生信号(响应治疗模式命令)以使得歧管阀从打开、充灌状态转换到闭合、治疗状态。 When the instruction operation in a treatment mode, the controller generates a signal (command mode in response to treatment) so that the manifold valve from opening, filling state to the closed state of the treatment. 当指示在充灌模式操作时,控制器产生信号(响应那个充灌模式命令)以使得歧管阀从闭合、治疗状态转换到打开、充灌状态。 When the instruction operation in filling mode, the controller generates a signal (in response to the filling mode command) such that the manifold valve is switched from the closed state to the open treatment, filling state. 本领域技术人员将认识到,上述的全部控制和用户命令功能通过结合一个或多个处理器实行,从而执行体现上述指令的程序,所述指令存储在当地存储器中。 Those skilled in the art will recognize that all of the above control and user commands to implement functions in conjunction with one or more processors to perform a program embodying these instructions, the instructions stored in the local memory.

[0160] 参照图4,在一个实施例中,两路或者两状态阀优选地定位在泵403的出口和泵401的出口之间的位置“V”处。 [0160] Referring to Figure 4, in one embodiment, where two or state of the valve is preferably positioned at a position between the outlet of the pump 403 and the pump outlet 401 of the "V" at. 在治疗模式,处于闭合位置的阀允许透析液流体流出泵403以循环通过歧管,通过端口F,并进入透析器430中。 In treatment mode, the valve is in the closed position allows the dialysate to circulate the fluid out of the pump through the manifold 403, through port F., And 430 into the dialyzer. 该透析液回路路径与血液回路流体隔离,在随偶数血液回路中血液流动通过泵401以循环出歧管,通过端口A并进入透析器430。 The dialysate circuit path fluidly isolated from the blood circuit, the blood circuit with the even flow of blood by a pump to circulate the manifold 401, through port A 430 and into the dialyzer. 相应地,在治疗模式,阀保证血液和透析液回路保持流体隔离。 Accordingly, in the therapy mode, valves ensure that the blood and dialysate circuit remains isolated from the fluid.

[0161] 在充灌模式中,阀将被打开,从而导致透析液流体流动通过泵403以在端口A通过歧管,进入到透析器430中,从透析器430出来,在端口G回到歧管中,并且在端口H从歧管出来。 [0161] In the filling mode, the valve is opened, causing the dialysate fluid flow through the pump 403 through the manifold at port A, into the dialyzer 430, 430 out from the dialyzer, back manifold port G tube and from the tube H in the port manifold. 相应地,在充灌模式中,阀保证透析液循环通过血液回路,从而布置血液和透析液回路为流体连通。 Accordingly, in a filling mode, the valve to ensure that the dialysate through the blood circulating circuit, so that the blood and dialysate circuit is arranged in fluid communication. 功能上,通过操控双路阀的状态,歧管布置在充灌模式中,优选地定位在歧管中的位置“V”。 Functionally, the dual control state of the valve, the manifold is arranged in a filling mode, the position is preferably located in the manifold of "V".

[0162] 在特定体积的透析液泵送进入和通过血液回路之后,双路阀闭合。 [0162] In certain dialysate pump volume after feeding into and through the blood circuit, two-way valve is closed. 透析液的泵送可以继续或者不继续。 Pumping dialysate can continue or not to continue. 如果继续,新的透析液循环仅通过透析液回路。 If you continue, the new dialysis fluid is circulated through the dialysate circuit only. 在血液回路中,剩余的透析液保留。 In the blood circuit, a dialysate remaining reserved. 为了从血液回路冲洗透析液,患者连接到“来自患者线路”1001,如图10所示,典型地称作动脉出入口线路。 In order to rinse the blood from the dialysate circuit, the patient is connected to the "from patient circuit" 1001, 10, typically referred to as the arterial line entrance. “到患者线路” 1923,典型地称作静脉返回线路,要么保持在废物容器上,要么连接到患者。 "The patient line" 1923, typically referred to as a venous return line, to either stay in the waste container, or connected to a patient.

[0163] 布置系统在治疗模式中,来自患者的血液被抽取到血液回路中,经由端口C通入歧管中,通过泵401,在端口A从歧管出来,通过透析器430,在端口G回到歧管,以及在端口H向后从歧管出来。 [0163] placement system in a mode of treatment, the blood from the patient is drawn into the blood circuit, via port C into the manifold by a pump 401, port A tube from the manifold, through the dialyzer 430, the port G Back to the manifold, and a port in the tube rearwardly from H manifold. 因此血液使得剩余的充灌流体“被驱赶”通过血液回路,从而移除在该工艺中保留的任何空气袋,并进入到废物容器或者患者二者之一中,其取决于静脉返回线路的连接状态。 Thus filling of the blood so that the remaining fluid "is driven" through the blood circuit, in order to remove any air pockets remaining in the process, and into the waste container in one or both of the patient, which depends on the venous return line is connected status. 在血液已经完全充灌血液回路后,系统停止血泵或者用户手动停止泵。 After the blood has completely filling the blood circuit, the blood pump system is stopped or the user manually stops the pump. 如果已经未连接,静脉返回线路然后连接到患者,治疗继续。 If you have not connected, then venous return line connected to the patient, the treatment continues.

[0164] 在另一个实施例中,过滤器,例如0.22 μ过滤器,可以用于帮助移除任何剩余的不期望的物质,如果吸附剂小罐不适于产生基本上消毒的透析液的话。 [0164] embodiment, the filter in another embodiment, for example, 0.22 μ filter may be used to help remove any remaining undesired material, if suitable for the sorbent canisters to produce a substantially sterile dialysate words. 在一个实施例中,过滤器定位成与具有紧邻歧管端口E的储存器输入线路串联,并且在充灌与操作过程中都被使用。 In one embodiment, the filter is positioned in series with the input line has a reservoir adjacent to the manifold port E, and are used during the filling operation.

[0165] 通过利用该充灌系统,避免必须使用额外的单独的一次性用品组来仅仅是充灌回路的血液。 [0165] By using the filling system, to avoid having to use additional separate disposable article groups to simply filling the blood circuit. 特别地,本发明消除对单独的盐水源,特别是I公升的盐水袋的需求,相应地,也消除对到单独的盐水源的连接器和管子的需要,包括用于连接血液线路到盐水的双腔长钉或者单腔长钉。 In particular, the present invention eliminates the need for a separate salt water, especially I liter saline bag, and accordingly, also eliminating the need for a separate saline source to the connector and the pipe, comprising a blood line connected to the brine dual chamber or single chamber spike spikes.

[0166] 尽管已经示出和描述目前认为是本发明的优选实施例的内容,但是,本领域技术人员应当理解,可以进行各种变化和修改,并且等效物可以替换其元件,而不脱离本发明的实际范围。 [0166] While there have been shown and described presently considered to be preferred embodiments of the present invention, those skilled in the art will appreciate, various changes and modifications may be made, and equivalents may be substituted for elements thereof without departing from the the actual scope of the invention. 此外,可以根据本发明的教导进行许多修改以适应特定情形或者材料,而不脱离本发明的中心范围。 In addition, many modifications may be made in accordance with the teachings of the present invention to adapt a particular situation or material without departing from the central scope of the present invention. 因此,意在的是,本发明并不限于作为实施本发明所能想到的最好的模式公开的特定实施例,而是本发明将包括落在所附权利要求的范围内的所有实施例。 Accordingly, it is intended that the present invention is not limited to the particular embodiment disclosed as the best mode contemplated embodiment of the present invention can be disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims (15)

1.一种能够在充灌模式和治疗模式下操作的透析治疗系统,包括: a.限定腔的壳体,所述腔能够容纳歧管,其中所述歧管包括: 1.包括第一层和第二层的塑料基板; ϋ.由所述第一层的第一表面和所述第二层的第一表面限定的第一流动路径; ii1.由所述第一层的第一表面和所述第二层的第一表面限定的第二流动路径;以及iv.与所述第一流动路径和所述第二流动路径都流体连通的阀,其中所述阀具有第一状态和第二状态,其中当处于所述第一状态时,所述第一流动路径和所述第二流动路径流体隔离,并且当处于所述第二状态时,所述第一流动路径和所述第二流动路径流体连通; V.模制到所述歧管中并定位在所述阀上方的膜片;以及b.物理附着到所述壳体的阀接口,其中所述阀接口配置为向所述膜片施加压力或从所述膜片移除压力以使得所述阀在所述第一状 1. A dialysis system capable of operating in a filling mode and treatment mode, comprising:. A housing defining a cavity, said cavity capable of receiving a manifold, wherein the manifold comprises: 1. a first layer comprising and a second plastic substrate layer; ϋ defined by the first surface of the first layer and the first surface of the second layer of the first flow path;.. ii1 by the first surface of the first layer, and the first surface of the second layer defining a second flow path;. and iv with said first flow path and the second flow path are in fluid communication with a valve, wherein the valve has a first state and a second state, wherein when in said first state, said first flow path and the second fluid flow path isolated, and when in said second state, said first flow and said second flow path fluid communication path; V. molded into the manifold and is positioned above the valve diaphragm; and b physically attached to the interface of the valve housing, wherein the valve membrane to the interface is configured to. applying pressure or a pressure piece is removed from the diaphragm so that the valve in the first shape 和所述第二状态之间切换;以及c.透析液储存器,其中,所述歧管的充灌通过利用来自所述透析液储存器而不是来自充灌流体的单独的源的透析液流体实施。 And between the second switching state; and c dialysate reservoir, wherein said filling manifold by using dialysate fluid from the dialysate reservoir, rather than from a separate source of fluid filling implementation.
2.如权利要求1所述的透析治疗系统,其中,所述歧管进一步包括:第一泵出口,其中所述第一泵出口接收由第一泵泵送的血液;第二泵出口,其中所述第二泵出口接收由第二泵泵送的透析液。 2. The dialysis system according to claim 1, wherein the manifold further comprises: a first pump outlet, wherein the outlet of the first pump receives the blood pumped by the first pump; a second pump outlet, receiving the second pump outlet dialysate pumped by the second pump.
3.如权利要求2所述的透析治疗系统,其中,所述阀定位为与所述第一泵出口和所述第二泵出口相邻。 Dialysis system according to claim 2, wherein said valve is positioned adjacent the outlet of the first pump and the second pump outlet.
4.如权利要求3所述的透析治疗系统,其中,当所述阀处于所述第一状态时,所述第一泵出口和所述第二泵出口彼此流体隔离。 4. The dialysis system according to claim 3, wherein, when the valve is in the first state, the first pump the second pump outlet and a fluid outlet isolated from one another.
5.如权利要求3所述的透析治疗系统,其中,当所述阀处于所述第二状态时,所述第一泵出口和所述第二泵出口彼此流体连通。 5. The dialysis system according to claim 3, wherein, when the valve is in the second state, the first pump and the second pump outlet fluid communication with each outlet.
6.如权利要求1所述的透析治疗系统,进一步包括控制器,其中所述控制器产生信号以使得所述阀在所述第一状态和所述第二状态之间切换。 6. The dialysis system according to claim 1, further comprising a controller, wherein the controller generates a signal to the valve such that the switching between the first state and the second state.
7.如权利要求6所述的透析治疗系统,其中,所述控制器产生信号以响应使所述透析治疗系统采用充灌模式进行操作的命令使得所述阀从所述第一状态切换到所述第二状态。 7. The dialysis system according to claim 6, wherein said controller generates a signal in response to the dialysis treatment using the filling system command mode operation such that the valve is switched from the first state to the said second state.
8.如权利要求6所述的透析治疗系统,其中,所述控制器产生信号以响应使所述透析治疗系统采用治疗模式进行操作的命令而使得所述阀从所述第二状态切换到所述第一状ίέτ O 8. The dialysis system according to claim 6, wherein said controller generates said signal in response to treatment with a dialysis treatment system command mode operation such that the valve is switched from the second state to the said first shaped ίέτ O
9.一种能够在充灌模式和治疗模式下操作的歧管,包括: a.包括第一层和第二层的塑料基板; b.由所述第一层的第一表面和所述第二层的第一表面限定的第一流动回路; c.由所述第一层的第一表面和所述第二层的第一表面限定的第二流动回路; d.与所述第一流动回路和所述第二流动回路都流体连通的阀,其中所述阀具有第一状态和第二状态,并且其中,当处于所述第一状态时,来自所述第一流动回路的流体不能进入所述第二流动回路,当处于所述第二状态时,来自所述第一流动回路的流体能够进入所述第二流动回路; e.模制到所述基板中并定位在所述阀上方的膜片; f.接收来自信号源的信号以通过向所述膜片施加压力或从所述膜片移除压力使得所述阀在所述第一状态和所述第二状态之间切换的接口,其中所述接口响应采用充灌模式进行操作的信号使 A manifold can be operated in a treatment mode and the filling mode, comprising: a plastic substrate comprising a first and second layers; b. A first surface of the first layer and the second. a first floor surface defining a first flow circuit; C defined by the first surface of the first layer and the first surface of the second layer of the second flow circuit;.. d with the first flow circuit and the second flow circuit are in fluid communication with a valve, wherein the valve has a first state and a second state, and wherein, when in the first state, fluid from the first flow circuit can not enter said second flow circuit, when in the second state, fluid from the first flow circuit to enter the second flow circuit;. e-molded to the substrate and positioned above the valve diaphragm;. f receives a signal from the signal source to the diaphragm by applying pressure to or removes pressure from the diaphragm such that the valve is switched between the first state and the second state an interface, wherein said interface in response to the operation mode using the filling signal causes 所述阀从所述第一状态切换到所述第二状态;并且所述接口响应采用治疗模式进行操作的信号使得所述阀从所述第二状态切换到所述第一状态。 The valve is switched from the first state to the second state; and the interface signal in response to treatment with the operation mode such that the valve is switched from the second state to the first state.
10.如权利要求9所述的歧管,其中,所述歧管进一步包括:第一泵出口,其中所述第一泵出口接收由第一泵泵送的血液;以及,第二泵出口,其中所述第二泵出口接收由第二泵泵送的透析液。 10. A manifold according to claim 9, wherein the manifold further comprises: a first pump outlet, wherein the outlet of the first pump receives a first pump blood from the pump; and a second pump outlet, wherein the second pump outlet is received by the second pump pumps the dialysate.
11.如权利要求10所述的歧管,其中,所述阀定位为与所述第一泵出口和所述第二泵出口相邻。 11. The manifold according to claim 10, wherein said valve is positioned adjacent the outlet of the first pump and the second pump outlet.
12.如权利要求11所述的歧管,其中,当所述阀处于所述第一状态时,所述第一泵出口和所述第二泵出口彼此流体隔离。 12. The manifold of claim 11, wherein, when the valve is in the first state, the first pump the second pump outlet and a fluid outlet isolated from one another.
13.如权利要求11所述的歧管,其中,当所述阀处于所述第二状态时,所述第一泵出口和所述第二泵出口彼此流体连通。 13. The manifold of claim 11, wherein, when the valve is in the second state, the first pump and the second pump outlet fluid communication with each outlet.
14.一种用于充灌用于透析治疗中的透析设备内的歧管的充灌方法,包括下述步骤: a.将所述歧管插入到所述透析设备中,其中所述歧管包括每个由基板限定的血液回路和透析液回路,以及与所述血液回路和所述透析液回路的每个流体连通的阀,其中所述阀具有第一状态和第二状态,并且其中当处于所述第一状态时,来自所述透析液回路的透析液流体不能进入所述血液回路,当处于所述第二状态时,来自所述透析液回路的透析液流体能够进入到所述血液回路中; b.布置所述阀在所述第二状态中; c.泵送透析液流体通过所述血液回路; d.布置所述阀在所述第一状态;以及e.从所述血液回路移除透析液流体;其中,所述透析液流体从透析液储存器泵送,而不从充灌流体的单独的源泵送。 14. A filling method for filling the manifold of the dialysis treatment in a dialysis apparatus, comprising the steps of:. A manifold tube is inserted into the said dialysis apparatus, wherein the manifold each comprising a substrate defining a blood circuit and the dialysate circuit, and the valve and the blood circuit and the dialysate circuit of each of the fluid communication, wherein the valve has a first state and a second state, and wherein when when in the first state, the dialysate fluid from the dialysate circuit can not enter the blood circuit, when in the second state, the dialysate fluid from the dialysate circuit to the blood can enter loop; b. said valve is disposed in said second state;. C through the blood pumping dialysate fluid circuit;. D disposed in the first state of the valve;. and e from the blood. removing the dialysate fluid circuit; wherein the fluid pumping the dialysate from the dialysate reservoir, rather than from a separate source of fluid filling pump.
15.如权利要求14所述的充灌方法,其中,所述阀通过通信来自定位在所述透析设备内的控制器的信号而布置在所述第一状态或者所述第二状态中。 15. The filling method according to claim 14, wherein the valve is arranged by a communication signal from said dialysis apparatus is positioned within a controller in the first state or the second state.
CN200980148019.8A 2008-10-07 2009-10-07 System and method for filling the dialysis system CN102307650B (en)

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